ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
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ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Employees
Employee
Years
Job
Industry
Nicole Barbato Nicole Barbato's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2005 - June 2008
Job Field Application Specialist
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals, Inc. August 2015 - Present
bioMerieux August 2014 - August 2015
Novartis August 2013 - August 2014
NewAgeSys, Inc September 2012 - August 2013
Reckitt Benckiser November 2008 - June 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - June 2008
Skills
Microbiology, FDA, USP, Quality Control, 21 CFR Part 11, Rapid Method..., Validation, Pharmaceutical Industry, Pharmaceutics, Change Control, Trackwise, Internal Audit, SAP, Laboratory Skills, Regulatory Affairs, cGMP practices, GMP, Aseptic Technique, Microbiological Quality..., Environmental Monitoring, Preservative Efficacy..., Stock Culture..., Virus Stock Production..., Media QC, EN1276, EN1650, EN13697, AOAC Use Dilution Test, MLT Testing, GLP, cGMP manufacturing, Laboratory, FDA GMP, Regulatory Submissions, Scan RDI, Microbial Quality..., AOAC Germicidal Spray..., AOAC GST Modified for..., GLP Analyst, Gram Staining, MET Testing, Microscopy, Sop, BactiFlow ALS, Analytical Method..., Regulatory Requirements, Workplace Organization, Efficent, Methodical, Biopharmaceuticals
Education
Rutgers, The State University of New Jersey-Newark 2002 — 2005
Bachelors, Biology
Regeneron Pharmaceuticals, Inc. August 2015 - Present
bioMerieux August 2014 - August 2015
Novartis August 2013 - August 2014
NewAgeSys, Inc September 2012 - August 2013
Reckitt Benckiser November 2008 - June 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - June 2008
Skills
Microbiology, FDA, USP, Quality Control, 21 CFR Part 11, Rapid Method..., Validation, Pharmaceutical Industry, Pharmaceutics, Change Control, Trackwise, Internal Audit, SAP, Laboratory Skills, Regulatory Affairs, cGMP practices, GMP, Aseptic Technique, Microbiological Quality..., Environmental Monitoring, Preservative Efficacy..., Stock Culture..., Virus Stock Production..., Media QC, EN1276, EN1650, EN13697, AOAC Use Dilution Test, MLT Testing, GLP, cGMP manufacturing, Laboratory, FDA GMP, Regulatory Submissions, Scan RDI, Microbial Quality..., AOAC Germicidal Spray..., AOAC GST Modified for..., GLP Analyst, Gram Staining, MET Testing, Microscopy, Sop, BactiFlow ALS, Analytical Method..., Regulatory Requirements, Workplace Organization, Efficent, Methodical, Biopharmaceuticals
Education
Rutgers, The State University of New Jersey-Newark 2002 — 2005
Bachelors, Biology
Brice Ludwig Brice Ludwig's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2012 - August 2012
Job Graduate Student at University of Delaware
Industry Research
Experience
University of Delaware 2015 - Present
Firmenich June 2014 - August 2014
Firmenich June 2013 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2012 - August 2012
Skills
Laboratory Skills, Cell Culture, Cell Biology, Immunology, Biochemistry, ELISA, PCR, Molecular Biology, Gel Electrophoresis, DNA extraction, Biotechnology, Laboratory
Education
University of Delaware 2015 — 2020
Doctor of Philosophy (PhD), Biochemistry
State University of New York College at Geneseo 2011 — 2015
Bachelor of Science (BS), Biochemistry
University of Delaware 2015 - Present
Firmenich June 2014 - August 2014
Firmenich June 2013 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2012 - August 2012
Skills
Laboratory Skills, Cell Culture, Cell Biology, Immunology, Biochemistry, ELISA, PCR, Molecular Biology, Gel Electrophoresis, DNA extraction, Biotechnology, Laboratory
Education
University of Delaware 2015 — 2020
Doctor of Philosophy (PhD), Biochemistry
State University of New York College at Geneseo 2011 — 2015
Bachelor of Science (BS), Biochemistry
Tara Lozy Tara Lozy's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience July 2011 - January 2014
Job Research Asscoiate
Industry Biotechnology
Experience
Lonza: A Global Leader In Life Sciences 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2011 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2007 - April 2010
Skills
Biotechnology, Manufacturing, Purification, Cell Culture, V&V, GMP, Sop, CAPA, Validation, Biopharmaceuticals, FDA, Aseptic Processing, Change Control, Technology Transfer, Life Sciences, 21 CFR Part 11
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2007
Bachelor of Science (BS), Biotechnology
Lonza: A Global Leader In Life Sciences 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2011 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2007 - April 2010
Skills
Biotechnology, Manufacturing, Purification, Cell Culture, V&V, GMP, Sop, CAPA, Validation, Biopharmaceuticals, FDA, Aseptic Processing, Change Control, Technology Transfer, Life Sciences, 21 CFR Part 11
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2007
Bachelor of Science (BS), Biotechnology
Sina Rezvan Sina Rezvan's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience July 2006 - December 2007
Job Insights Account Manager at StreamSend
Industry Information Technology and Services
Experience
StreamSend 2015 - Present
Direct Eats September 2014 - July 2015
Pavé Life May 2014 - September 2014
Pavé Life May 2013 - April 2014
Genie's Hookah Lounge & Restaurant September 2010 - November 2012
ImClone Systems Inc. February 2010 - August 2010
ImClone Systems January 2008 - February 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
Skills
GMP, Sop, Validation, Cell Culture, Biopharmaceuticals, Aseptic Technique, V&V, Biotechnology, Quality Assurance, FDA, Technology Transfer, Sales, Lifesciences, Start-ups, National Accounts, Customer Acquisition, Social Media Consulting, Account Management, National Account..., Social Media, Social Media Marketing, Customer Service, Customer Retention, National Account..., Social Media Strategist, Social Media Advertising, Salesforce.com, Long-term Customer..., Marketing Strategy, Relationship Marketing, Sales Process, Vendor Relationships, Relationship Management, Direct Sales, Strategy, Training, CRM, Leadership, Management, Marketing, Event Planning
Education
Rutgers University-New Brunswick 2001 — 2006
BA, Genetics
University of Scranton 2014 — 2016
Master of Business Administration (M.B.A.), With a specialization in Operations Management, 3.94 GPA
Rutgers University-New Brunswick 2001 — 2006
BA, Psychology
StreamSend 2015 - Present
Direct Eats September 2014 - July 2015
Pavé Life May 2014 - September 2014
Pavé Life May 2013 - April 2014
Genie's Hookah Lounge & Restaurant September 2010 - November 2012
ImClone Systems Inc. February 2010 - August 2010
ImClone Systems January 2008 - February 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
Skills
GMP, Sop, Validation, Cell Culture, Biopharmaceuticals, Aseptic Technique, V&V, Biotechnology, Quality Assurance, FDA, Technology Transfer, Sales, Lifesciences, Start-ups, National Accounts, Customer Acquisition, Social Media Consulting, Account Management, National Account..., Social Media, Social Media Marketing, Customer Service, Customer Retention, National Account..., Social Media Strategist, Social Media Advertising, Salesforce.com, Long-term Customer..., Marketing Strategy, Relationship Marketing, Sales Process, Vendor Relationships, Relationship Management, Direct Sales, Strategy, Training, CRM, Leadership, Management, Marketing, Event Planning
Education
Rutgers University-New Brunswick 2001 — 2006
BA, Genetics
University of Scranton 2014 — 2016
Master of Business Administration (M.B.A.), With a specialization in Operations Management, 3.94 GPA
Rutgers University-New Brunswick 2001 — 2006
BA, Psychology
Brian Goss Brian Goss's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2007 - Present
Job Associate Director of Validation at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2007 - Present
Centocor – GBSC J&J Family of Companies June 2004 - October 2007
Centocor, Inc March 2002 - June 2004
Centocor, Inc March 2001 - March 2002
Centocor, Inc January 1999 - March 2001
Skills
21 CFR Part 11, CAPA, GMP, Aseptic Processing, Change Control, GxP, Sop, FDA, Computer System..., Biopharmaceuticals, V&V, Biotechnology, Validation, Pharmaceutical Industry
Education
Temple University
Master of Quality Assurance and Regulatory Affairs
Temple University
Bachelor of Science (B.S.), Biology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2007 - Present
Centocor – GBSC J&J Family of Companies June 2004 - October 2007
Centocor, Inc March 2002 - June 2004
Centocor, Inc March 2001 - March 2002
Centocor, Inc January 1999 - March 2001
Skills
21 CFR Part 11, CAPA, GMP, Aseptic Processing, Change Control, GxP, Sop, FDA, Computer System..., Biopharmaceuticals, V&V, Biotechnology, Validation, Pharmaceutical Industry
Education
Temple University
Master of Quality Assurance and Regulatory Affairs
Temple University
Bachelor of Science (B.S.), Biology
Rohini Dhulipala's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2009 - August 2009
Job Scientist III Mfg. Sci NPI at Thermo Fisher Scientific (Life Technologies)
Industry Biotechnology
Experience
Thermo Fisher Scientific (Life Technologies) February 2011 - Present
Life Technologies July 2010 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - August 2009
GE Healthcare May 2007 - January 2009
Amicus Therapeutics September 2005 - May 2007
GSK April 2005 - August 2005
GE Healthcare March 2002 - March 2005
Amersham Biosciences January 2001 - February 2002
Amersham Biosciences February 1999 - December 2001
Penn UNIVERSITY OF PENSYLVANIA January 1996 - January 1999
Skills
Cell Culture, Biotechnology, Molecular Biology, Protein Chemistry, Validation, Genomics, Life Sciences, RT-PCR, Assay Development, Drug Discovery, Purification, Protein Purification, Lifesciences, Biochemistry, DNA, PCR, Chromatography, Project Management, ELISA, Sop, Operations Process..., Infrastructure for NPI, Project Coordination, Gage R&R, Product Development, Product Launch, Lean Six Sigma, MSA, SAP ERP, Oracle Agile PLM, Teamwork, FDA, SOP
Education
Sri Venkateswara University 1986 — 1990
Master's degree
Thermo Fisher Scientific (Life Technologies) February 2011 - Present
Life Technologies July 2010 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - August 2009
GE Healthcare May 2007 - January 2009
Amicus Therapeutics September 2005 - May 2007
GSK April 2005 - August 2005
GE Healthcare March 2002 - March 2005
Amersham Biosciences January 2001 - February 2002
Amersham Biosciences February 1999 - December 2001
Penn UNIVERSITY OF PENSYLVANIA January 1996 - January 1999
Skills
Cell Culture, Biotechnology, Molecular Biology, Protein Chemistry, Validation, Genomics, Life Sciences, RT-PCR, Assay Development, Drug Discovery, Purification, Protein Purification, Lifesciences, Biochemistry, DNA, PCR, Chromatography, Project Management, ELISA, Sop, Operations Process..., Infrastructure for NPI, Project Coordination, Gage R&R, Product Development, Product Launch, Lean Six Sigma, MSA, SAP ERP, Oracle Agile PLM, Teamwork, FDA, SOP
Education
Sri Venkateswara University 1986 — 1990
Master's degree
Eric Hermann Eric Hermann's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2012 - August 2012
Job Student at Stanford University
Industry Biotechnology
Experience
Bain & Company June 2014 - August 2014
Stanford Sierra Conference Center June 2013 - September 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2012 - August 2012
Skills
Matlab, Microsoft Office, Research, PowerPoint, Microsoft Excel, Microsoft Word, Teamwork, Data Analysis, Public Speaking, Leadership, Statistics, English, Customer Service, Project Management, Team Leadership, Teaching, Java, C++, Computer Science
Education
Stanford University 2015 — 2016
Master of Science (M.S.), Computer Science
Stanford University 2011 — 2015
Bachelor of Science (BS), Biomechanical Engineering
Bain & Company June 2014 - August 2014
Stanford Sierra Conference Center June 2013 - September 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2012 - August 2012
Skills
Matlab, Microsoft Office, Research, PowerPoint, Microsoft Excel, Microsoft Word, Teamwork, Data Analysis, Public Speaking, Leadership, Statistics, English, Customer Service, Project Management, Team Leadership, Teaching, Java, C++, Computer Science
Education
Stanford University 2015 — 2016
Master of Science (M.S.), Computer Science
Stanford University 2011 — 2015
Bachelor of Science (BS), Biomechanical Engineering
Brianna Costabile Brianna Costabile's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2013 - August 2013
Job Graduate Student at Columbia University Medical Center
Industry Biotechnology
Experience
Columbia University Medical Center August 2015 - Present
Rutgers University June 2014 - July 2015
Rutgers University January 2012 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2013 - August 2013
Belmont Market August 2011 - August 2012
Skills
Biotechnology, Molecular Biology, PCR, Microbiology, Gel Electrophoresis, DNA extraction, Biochemistry, Agarose Gel..., DNA, Lifesciences, Electrophoresis, Chromatography, Genetics, recombinant DNA..., DNA sequencing, HPLC, RT-PCR, UV/Vis, RNA isolation, Molecular Cloning, Genotyping, Laboratory, Microscopy, qPCR
Education
Rutgers University-New Brunswick 2010 — 2014
Bachelor of Science (BS), Biotechnology
Columbia University Medical Center August 2015 - Present
Rutgers University June 2014 - July 2015
Rutgers University January 2012 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2013 - August 2013
Belmont Market August 2011 - August 2012
Skills
Biotechnology, Molecular Biology, PCR, Microbiology, Gel Electrophoresis, DNA extraction, Biochemistry, Agarose Gel..., DNA, Lifesciences, Electrophoresis, Chromatography, Genetics, recombinant DNA..., DNA sequencing, HPLC, RT-PCR, UV/Vis, RNA isolation, Molecular Cloning, Genotyping, Laboratory, Microscopy, qPCR
Education
Rutgers University-New Brunswick 2010 — 2014
Bachelor of Science (BS), Biotechnology
Daisy Louro Daisy Louro's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2010 - July 2010
Job Senior Specialist Microbiology
Industry Pharmaceuticals
Experience
Ferring Pharmaceuticals October 2013 - Present
Actavis October 2012 - October 2013
Dendreon July 2010 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - July 2010
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. June 2005 - July 2010
Rutgers University October 2004 - May 2005
Skills
Cell Culture, Genetic Sequencing, Strain Typing, LIMS, Sequencing, Sop, Microbiology, Aseptic Technique
Education
Seton Hall University 2006 — 2009
Masters, Microbiology, 3.7
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
Bachelor of Science, Biology
Ferring Pharmaceuticals October 2013 - Present
Actavis October 2012 - October 2013
Dendreon July 2010 - November 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - July 2010
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. June 2005 - July 2010
Rutgers University October 2004 - May 2005
Skills
Cell Culture, Genetic Sequencing, Strain Typing, LIMS, Sequencing, Sop, Microbiology, Aseptic Technique
Education
Seton Hall University 2006 — 2009
Masters, Microbiology, 3.7
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
Bachelor of Science, Biology
Bankim Patel Bankim Patel's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2011 - April 2015
Job Senior Director, Engineering & Validation
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2008 - January 2011
Bristol-Myers Squibb Co. January 2007 - February 2008
ImClone Systems December 2000 - January 2007
Merck February 1997 - December 2000
Skills
Engineering, Regulatory Requirements, Validation, 21 CFR Part 11, Project Management, Biotechnology, GMP, Project Engineering, Leadership, Pharmaceutical Industry, Automation, Biopharmaceuticals, Vendor Management, FDA, Quality Assurance, Management, Sop, Construction Management, Document Management, Facilities Management, Change Control, Process Improvement, V&V, Technology Transfer, Quality System, GLP, Regulatory Submissions, CAPA, Clinical Development, GxP, ISO 13485, Computer System..., Aseptic Processing, Process Simulation, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1980 — 1984
Bachelor of Science, Mechanical Engineering
Alexion Pharmaceuticals, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2008 - January 2011
Bristol-Myers Squibb Co. January 2007 - February 2008
ImClone Systems December 2000 - January 2007
Merck February 1997 - December 2000
Skills
Engineering, Regulatory Requirements, Validation, 21 CFR Part 11, Project Management, Biotechnology, GMP, Project Engineering, Leadership, Pharmaceutical Industry, Automation, Biopharmaceuticals, Vendor Management, FDA, Quality Assurance, Management, Sop, Construction Management, Document Management, Facilities Management, Change Control, Process Improvement, V&V, Technology Transfer, Quality System, GLP, Regulatory Submissions, CAPA, Clinical Development, GxP, ISO 13485, Computer System..., Aseptic Processing, Process Simulation, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick 1980 — 1984
Bachelor of Science, Mechanical Engineering
David Allara David Allara's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2009 - Present
Job Senior Quality Assurance Specialist at Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2009 - Present
Johnson & Johnson June 2008 - October 2009
Colgate Palmolive November 2007 - June 2008
Skills
Quality System, Quality Assurance, Validation, FDA, CAPA, GMP, Quality Control, Laboratory, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, SOP
Education
Rutgers University-New Brunswick 2004 — 2008
Bachelor's degree, Chemistry
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2009 - Present
Johnson & Johnson June 2008 - October 2009
Colgate Palmolive November 2007 - June 2008
Skills
Quality System, Quality Assurance, Validation, FDA, CAPA, GMP, Quality Control, Laboratory, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, SOP
Education
Rutgers University-New Brunswick 2004 — 2008
Bachelor's degree, Chemistry
Philip Calabrese's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2007 - May 2008
Job Cofounder at Boom Algae
Industry Higher Education
Experience
Boom Algae November 2012 - Present
University of Colorado at Boulder May 2008 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - May 2008
OnPont Tutoring, LLC August 2005 - April 2008
Langan International LLC May 2001 - December 2001
Skills
AutoCAD, Molecular Cloning, Molecular Biology, Microscopy, Protein Expression, Cell, Chemistry, Laboratory, Assay Development, DNA sequencing, Data Analysis, SDS-PAGE, HPLC, Public Speaking, In Vitro, Cell Culture, Biochemistry
Education
University of Colorado at Boulder 2008 — 2014
Doctor of Philosophy (Ph.D.), Biochemistry
Rutgers University 2003 — 2005
Bachelor of Science, Biochemistry, Philosophy
Stevens Institute of Technology 2000 — 2003
N/A, Civil Engineering
Boom Algae November 2012 - Present
University of Colorado at Boulder May 2008 - May 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - May 2008
OnPont Tutoring, LLC August 2005 - April 2008
Langan International LLC May 2001 - December 2001
Skills
AutoCAD, Molecular Cloning, Molecular Biology, Microscopy, Protein Expression, Cell, Chemistry, Laboratory, Assay Development, DNA sequencing, Data Analysis, SDS-PAGE, HPLC, Public Speaking, In Vitro, Cell Culture, Biochemistry
Education
University of Colorado at Boulder 2008 — 2014
Doctor of Philosophy (Ph.D.), Biochemistry
Rutgers University 2003 — 2005
Bachelor of Science, Biochemistry, Philosophy
Stevens Institute of Technology 2000 — 2003
N/A, Civil Engineering
Don Krey Don Krey's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2012 - March 2013
Job Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company March 2015 - Present
Eli Lilly and Company August 2014 - Present
Eli Lilly and Company March 2013 - August 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - March 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2011 - April 2012
GE Healthcare November 2009 - April 2011
Gemin X Pharmaceuticals, Inc November 2004 - November 2009
J&J PRD (at Centocor) January 2002 - November 2003
McNeil Consumer & Specialty Pharmaceuticals 1998 - January 2002
Skills
GLP, GMP, Validation, GCP, GxP, Clinical Research, V&V, Pharmaceutical Industry, FDA, 21 CFR Part 11, CAPA, Computer System..., Medical Root Cause..., Medical Deviation..., Medical Change..., Drug Development, Lifesciences, Clinical Trials, Sop, Biotechnology, Technology Transfer, Oncology, Clinical Development, CRO, Drug Discovery, R&D, Quality Assurance
Education
Temple University 2003 — 2007
M.S., Quality Assurance/Regulatory Affairs
University of Scranton
B.S, Biology
Eli Lilly and Company March 2015 - Present
Eli Lilly and Company August 2014 - Present
Eli Lilly and Company March 2013 - August 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - March 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2011 - April 2012
GE Healthcare November 2009 - April 2011
Gemin X Pharmaceuticals, Inc November 2004 - November 2009
J&J PRD (at Centocor) January 2002 - November 2003
McNeil Consumer & Specialty Pharmaceuticals 1998 - January 2002
Skills
GLP, GMP, Validation, GCP, GxP, Clinical Research, V&V, Pharmaceutical Industry, FDA, 21 CFR Part 11, CAPA, Computer System..., Medical Root Cause..., Medical Deviation..., Medical Change..., Drug Development, Lifesciences, Clinical Trials, Sop, Biotechnology, Technology Transfer, Oncology, Clinical Development, CRO, Drug Discovery, R&D, Quality Assurance
Education
Temple University 2003 — 2007
M.S., Quality Assurance/Regulatory Affairs
University of Scranton
B.S, Biology
Gail Ciabatoni Gail Ciabatoni's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2009 - December 2012
Job
Industry Pharmaceuticals
Experience
R & D Partners January 2014 - Present
InVentiv Health Clinical August 2013 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - December 2012
Akros Pharma, Inc. 2006 - 2009
Skills
Data Management, Oncology, EDC, 21 CFR Part 11, CRO, CDISC SDTM, Protocol, Pharmaceutical Industry, SDTM, Therapeutic Areas, Clinical Trials, ICH-GCP, Clinical Data Management, Infectious Diseases, CTMS, GCP
Education
Stockton University (formerly Richard Stockton College)
Bachelor of Science (B.S.), Biology, General
R & D Partners January 2014 - Present
InVentiv Health Clinical August 2013 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - December 2012
Akros Pharma, Inc. 2006 - 2009
Skills
Data Management, Oncology, EDC, 21 CFR Part 11, CRO, CDISC SDTM, Protocol, Pharmaceutical Industry, SDTM, Therapeutic Areas, Clinical Trials, ICH-GCP, Clinical Data Management, Infectious Diseases, CTMS, GCP
Education
Stockton University (formerly Richard Stockton College)
Bachelor of Science (B.S.), Biology, General
Angela Windt Angela Windt's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2003 - May 2005
Job Senior Director, Regulatory Strategy at Advyzom
Industry Biotechnology
Experience
Advyzom July 2012 - Present
Roche August 2009 - June 2012
Roche July 2007 - August 2009
Roche July 2006 - July 2007
Walgreens January 2006 - April 2007
Roche July 2005 - July 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2003 - May 2005
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
Pharm.D., Pharmacy
Taylor University 1995 — 1999
BA, Biology
Advyzom July 2012 - Present
Roche August 2009 - June 2012
Roche July 2007 - August 2009
Roche July 2006 - July 2007
Walgreens January 2006 - April 2007
Roche July 2005 - July 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2003 - May 2005
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
Pharm.D., Pharmacy
Taylor University 1995 — 1999
BA, Biology
Jill Woods's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2006 - December 2008
Job Quality Assurance Professional within Pharmaceuticals, Biotechnology, and Medical Devices
Industry Biotechnology
Experience
Independent Consultant January 2013 - Present
Savient Pharmaceuticals, Inc. January 2012 - December 2012
Medidata Solutions December 2008 - December 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2006 - December 2008
NexMed, Inc. January 2003 - December 2005
PAREXEL September 1999 - January 2003
Skills
Validation, CAPA, GMP, FDA, Quality Assurance, Change Control, SOP, Quality System, Pharmacovigilance, Computer System..., Pharmaceutical Industry, Quality Management, 21 CFR Part 11, Medical Devices, GCP, Microsoft Excel, GxP, Regulatory Requirements, Clinical Trials, GLP, Training, Pharmaceutics, Access, Regulatory Affairs, TrackWise, Microsoft Word, Visio, Cross-functional Team..., HTML, DocuShare, cGMP, HIPAA, RAVE, PowerPoint, Paintshop Pro, Adobe Connect, Microsoft Access, Microsoft PowerPoint, Microsoft Project, Microsoft Visio, MS Project, Hope
Education
Rutgers University-New Brunswick
Bachelor's, Biochemistry, Psychology
Independent Consultant January 2013 - Present
Savient Pharmaceuticals, Inc. January 2012 - December 2012
Medidata Solutions December 2008 - December 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2006 - December 2008
NexMed, Inc. January 2003 - December 2005
PAREXEL September 1999 - January 2003
Skills
Validation, CAPA, GMP, FDA, Quality Assurance, Change Control, SOP, Quality System, Pharmacovigilance, Computer System..., Pharmaceutical Industry, Quality Management, 21 CFR Part 11, Medical Devices, GCP, Microsoft Excel, GxP, Regulatory Requirements, Clinical Trials, GLP, Training, Pharmaceutics, Access, Regulatory Affairs, TrackWise, Microsoft Word, Visio, Cross-functional Team..., HTML, DocuShare, cGMP, HIPAA, RAVE, PowerPoint, Paintshop Pro, Adobe Connect, Microsoft Access, Microsoft PowerPoint, Microsoft Project, Microsoft Visio, MS Project, Hope
Education
Rutgers University-New Brunswick
Bachelor's, Biochemistry, Psychology
Bhumi Dave's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience December 2007 - March 2008
Job Sr. Business Analyst at DIVERSANT, LLC BristolMyers Squibb
Industry Pharmaceuticals
Experience
DIVERSANT, LLC - Bristol-Myers Squibb July 2015 - Present
Merck Pharmaceuticals January 2015 - June 2015
M Moser Associates December 2014 - January 2015
Guttha Global LLC December 2013 - October 2014
Hoffmann-La Roche September 2009 - November 2013
Taylor Technology January 2009 - June 2009
ADECCO – Piscataway, NJ
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - March 2008
ATRIUM – Edison, NJ
Skills
Project Coordination, Business Analysis, Project Management, Media & Entertainment, Requirements Gathering, Ariba, BRD, Wireframes, Visio, SharePoint, RequisitePro, Event Management, RUP Methodologies, Technical Writing, Risk Management, Data Management, Validation, FRD, User Acceptance Testing, Immunology, LIMS, IND, Immunoassays, Research, Regulatory Submissions, Microsoft Excel, DMPK, GLP, Bioanalysis, MS Office Suite, SOP, PowerPoint, GxP, Lotus Notes, RAPID (Report writing..., Outlook, Windows, JMP, cGMP, SoftMax Pro, Watson, GD Template, In-Vitro, Biotechnology, In Vivo, Entertainment, Documentum, Spotfire, JIRA
Education
Rutgers, The State University of New Jersey-New Brunswick 2013 — 2013
MINI-MBA CERTIFICATE, BIOPHARMA INNOVATION, A
Rutgers, The State University of New Jersey-Newark 2003 — 2007
Bachelors, Biology
Mt. San Jacinto Community College 2000 — 2003
A.A., Liberal Arts
Hemet High School 1999 — 2000
High School Diploma, High School/Secondary Diplomas and Certificates
DIVERSANT, LLC - Bristol-Myers Squibb July 2015 - Present
Merck Pharmaceuticals January 2015 - June 2015
M Moser Associates December 2014 - January 2015
Guttha Global LLC December 2013 - October 2014
Hoffmann-La Roche September 2009 - November 2013
Taylor Technology January 2009 - June 2009
ADECCO – Piscataway, NJ
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - March 2008
ATRIUM – Edison, NJ
Skills
Project Coordination, Business Analysis, Project Management, Media & Entertainment, Requirements Gathering, Ariba, BRD, Wireframes, Visio, SharePoint, RequisitePro, Event Management, RUP Methodologies, Technical Writing, Risk Management, Data Management, Validation, FRD, User Acceptance Testing, Immunology, LIMS, IND, Immunoassays, Research, Regulatory Submissions, Microsoft Excel, DMPK, GLP, Bioanalysis, MS Office Suite, SOP, PowerPoint, GxP, Lotus Notes, RAPID (Report writing..., Outlook, Windows, JMP, cGMP, SoftMax Pro, Watson, GD Template, In-Vitro, Biotechnology, In Vivo, Entertainment, Documentum, Spotfire, JIRA
Education
Rutgers, The State University of New Jersey-New Brunswick 2013 — 2013
MINI-MBA CERTIFICATE, BIOPHARMA INNOVATION, A
Rutgers, The State University of New Jersey-Newark 2003 — 2007
Bachelors, Biology
Mt. San Jacinto Community College 2000 — 2003
A.A., Liberal Arts
Hemet High School 1999 — 2000
High School Diploma, High School/Secondary Diplomas and Certificates
Renee Sojcher, MS, CHWC Renee Sojcher, MS, CHWC's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 1988 - April 1989
Job Health and Wellness Consultant, Behavior Change Specialist, Health and Wellness Coach, Writer, Speaker, Teacher
Industry Health, Wellness and Fitness
Experience
WellHealth LLC May 2012 - October 2014
One-on-one Private Tutoring January 2001 - June 2014
CAHAL 2012 - 2013
Neshoma, Inc. November 2002 - July 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 1988 - April 1989
Oncogene Science December 1986 - July 1988
Skills
Stress Management, Wellness Coaching, Holistic Health, Nutrition, Wellness, Mindfulness, Coaching, Lifestyle Coaching, Health, Teaching, Health Education, Lifestyle Management, Wellbeing, Weight Management, Mental Health, Lifestyle, Prevention, Stress, Chronic Illness, Fitness, Published Author, Healing, Meditation, Nutritional Counseling, Yoga, Alternative Medicine, Health Coaching, Writing Skills, Healthy Lifestyle, Mindful Eating, Behavior Change, Motivational..., Goal Setting, Social Cognitive Theory, Appreciative Inquiry
Education
Rutgers, The State University of New Jersey-Newark 2012 — 2015
Master's Degree, Health Science
Wellcoaches 2012 — 2012
CHWC, Health and Welness Coaching
Yeshiva University 1980 — 1986
M.S., Molecular Biology
WellHealth LLC May 2012 - October 2014
One-on-one Private Tutoring January 2001 - June 2014
CAHAL 2012 - 2013
Neshoma, Inc. November 2002 - July 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 1988 - April 1989
Oncogene Science December 1986 - July 1988
Skills
Stress Management, Wellness Coaching, Holistic Health, Nutrition, Wellness, Mindfulness, Coaching, Lifestyle Coaching, Health, Teaching, Health Education, Lifestyle Management, Wellbeing, Weight Management, Mental Health, Lifestyle, Prevention, Stress, Chronic Illness, Fitness, Published Author, Healing, Meditation, Nutritional Counseling, Yoga, Alternative Medicine, Health Coaching, Writing Skills, Healthy Lifestyle, Mindful Eating, Behavior Change, Motivational..., Goal Setting, Social Cognitive Theory, Appreciative Inquiry
Education
Rutgers, The State University of New Jersey-Newark 2012 — 2015
Master's Degree, Health Science
Wellcoaches 2012 — 2012
CHWC, Health and Welness Coaching
Yeshiva University 1980 — 1986
M.S., Molecular Biology
Poonam Kapadia Poonam Kapadia's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2010 - April 2010
Job Chemist at Tyco Fire Protection
Industry Chemicals
Experience
Tyco Fire Protection June 2015 - Present
Church & Dwight, Co., Inc. March 2013 - May 2015
Church & Dwight, Co., Inc. May 2011 - February 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2010 - April 2010
University of Medicine and Dentistry of New Jersey August 2008 - May 2009
Skills
Laboratory, Formulation, R&D, Wet Chemistry, Data Analysis, PowerPoint, Laundry, Microsoft Word, Chemistry, Research, Surfactants, PCR, Word, Product Development, GMP, Consumer Products, Cross-functional Team..., GLP, SOP, Fabric Care
Education
Saint Peter's University 2005 — 2009
Bachelor, Biochemistry and Biotechnology
Tyco Fire Protection June 2015 - Present
Church & Dwight, Co., Inc. March 2013 - May 2015
Church & Dwight, Co., Inc. May 2011 - February 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2010 - April 2010
University of Medicine and Dentistry of New Jersey August 2008 - May 2009
Skills
Laboratory, Formulation, R&D, Wet Chemistry, Data Analysis, PowerPoint, Laundry, Microsoft Word, Chemistry, Research, Surfactants, PCR, Word, Product Development, GMP, Consumer Products, Cross-functional Team..., GLP, SOP, Fabric Care
Education
Saint Peter's University 2005 — 2009
Bachelor, Biochemistry and Biotechnology
Sonia Gomes's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2008 - Present
Job Scientist at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - Present
Zeus Scientific January 2005 - June 2008
Skills
HPLC, SDS-PAGE, Capillary..., Isoelectric Focusing, Capillary Isoelectric..., UPLC, Formulation, Analytical Sciences, ELISA, Athena, LIMS, GMP, Assay Development, Biopharmaceuticals, Purification, Chromatography, Biotechnology, Life Sciences, Protein Chemistry, Validation, GLP
Education
Rutgers University 2006 — 2009
Master of Science (MS), Biology
Rutgers University 2000 — 2004
Bachelor of Arts (BA), Biology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - Present
Zeus Scientific January 2005 - June 2008
Skills
HPLC, SDS-PAGE, Capillary..., Isoelectric Focusing, Capillary Isoelectric..., UPLC, Formulation, Analytical Sciences, ELISA, Athena, LIMS, GMP, Assay Development, Biopharmaceuticals, Purification, Chromatography, Biotechnology, Life Sciences, Protein Chemistry, Validation, GLP
Education
Rutgers University 2006 — 2009
Master of Science (MS), Biology
Rutgers University 2000 — 2004
Bachelor of Arts (BA), Biology
Samer Nuwayhid Samer Nuwayhid's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience July 2007 - October 2008
Job Research Associate at Children's National Medical Center
Industry Biotechnology
Experience
Center for Neuroscience, Children’s National Medical Center October 2009 - Present
Wayne State University October 2008 - October 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2007 - October 2008
Sunesis Pharmaceuticals November 2005 - April 2007
New York University School of Medicine October 2004 - November 2005
The George Washington University Medical Center May 2000 - September 2004
National Cancer Institute January 1999 - April 2000
Skills
Biochemistry, Cell Biology, Molecular Biology, Western Blotting, Protein Purification, Cell Culture, Protein Expression, Molecular Cloning, Drug Discovery, Microscopy, HPLC, Lifesciences, Cancer, Biotechnology, ELISA, PCR, SDS-PAGE, Neuroscience, In Vitro, RT-PCR, Antibodies, Assay Development, Cell, Cell Signaling
Education
Samford University 1993 — 1996
B.S., Biology
Center for Neuroscience, Children’s National Medical Center October 2009 - Present
Wayne State University October 2008 - October 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2007 - October 2008
Sunesis Pharmaceuticals November 2005 - April 2007
New York University School of Medicine October 2004 - November 2005
The George Washington University Medical Center May 2000 - September 2004
National Cancer Institute January 1999 - April 2000
Skills
Biochemistry, Cell Biology, Molecular Biology, Western Blotting, Protein Purification, Cell Culture, Protein Expression, Molecular Cloning, Drug Discovery, Microscopy, HPLC, Lifesciences, Cancer, Biotechnology, ELISA, PCR, SDS-PAGE, Neuroscience, In Vitro, RT-PCR, Antibodies, Assay Development, Cell, Cell Signaling
Education
Samford University 1993 — 1996
B.S., Biology
Nick Palatzoukas Nick Palatzoukas's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2013 - July 2013
Job Molecular Biology Technician at GeneDx
Industry Biotechnology
Experience
GeneDx July 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2013 - July 2013
Rutgers University May 2012 - March 2013
Skills
Food Safety, PowerPoint, Food, Microsoft Office, Microsoft Excel, Time Management, Research, Customer Service, Microsoft Word, Teamwork, Food & Beverage, Cooking, Public Speaking, Food Service, Event Planning, Data Analysis, Leadership, Critical Thinking, Hospitality, Catering, Microbiology, Biochemistry
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2012
microbiology, biochemistry, graduated
St. Petersburg College
GeneDx July 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2013 - July 2013
Rutgers University May 2012 - March 2013
Skills
Food Safety, PowerPoint, Food, Microsoft Office, Microsoft Excel, Time Management, Research, Customer Service, Microsoft Word, Teamwork, Food & Beverage, Cooking, Public Speaking, Food Service, Event Planning, Data Analysis, Leadership, Critical Thinking, Hospitality, Catering, Microbiology, Biochemistry
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2012
microbiology, biochemistry, graduated
St. Petersburg College
Gwenn Andahazy, Ed.M Gwenn Andahazy, Ed.M's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2007 - June 2011
Job Teacher Chemistry and Environmental Science at Lawrence Township Public Schools
Industry Writing and Editing
Experience
Lawrence Township Public Schools September 2011 - Present
Mercer County Community College August 2011 - Present
J. G. Andahazy June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2007 - June 2011
Skills
Editing, Blogging, Leadership Development, Management, Content Development, Project Management, Instructional Design, Leadership, Event Planning, Program Management, Coaching, Course development, Curriculum development, Content management
Education
Rutgers University-New Brunswick 1991 — 2000
Masters in Education, Chemistry, Environmental Science, Geoscience, Science Education
Lawrence Township Public Schools September 2011 - Present
Mercer County Community College August 2011 - Present
J. G. Andahazy June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2007 - June 2011
Skills
Editing, Blogging, Leadership Development, Management, Content Development, Project Management, Instructional Design, Leadership, Event Planning, Program Management, Coaching, Course development, Curriculum development, Content management
Education
Rutgers University-New Brunswick 1991 — 2000
Masters in Education, Chemistry, Environmental Science, Geoscience, Science Education
Peggy Velardo Peggy Velardo's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2010 - January 2012
Job QC Manager Stability and Regulatory Specification Management, Eli Lilly and Company New Jersey
Industry Biotechnology
Experience
Eli Lilly and Company November 2013 - Present
Eli Lilly and Company January 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2010 - January 2012
ImClone Systems June 2004 - November 2010
Centocor April 2002 - May 2004
Nextran 1992 - 2002
DNX 1992 - 2002
Skills
Sop, Technology Transfer, Quality Control, GMP, LIMS, Software Documentation, Laboratory, Biochemistry, Biopharmaceuticals, Assay Development, Validation, FDA, Biotechnology, HPLC, Quality System, SOP, 21 CFR Part 11, GLP, Change Control, Pharmaceutical Industry, CAPA, GxP, Life Sciences, Quality Assurance, Computer System...
Education
University of Notre Dame 1985 — 1992
MA, Biochemistry
Seton Hall University 1984 — 1988
BS, Chemistry, Physics, Cum Laude
Eli Lilly and Company November 2013 - Present
Eli Lilly and Company January 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2010 - January 2012
ImClone Systems June 2004 - November 2010
Centocor April 2002 - May 2004
Nextran 1992 - 2002
DNX 1992 - 2002
Skills
Sop, Technology Transfer, Quality Control, GMP, LIMS, Software Documentation, Laboratory, Biochemistry, Biopharmaceuticals, Assay Development, Validation, FDA, Biotechnology, HPLC, Quality System, SOP, 21 CFR Part 11, GLP, Change Control, Pharmaceutical Industry, CAPA, GxP, Life Sciences, Quality Assurance, Computer System...
Education
University of Notre Dame 1985 — 1992
MA, Biochemistry
Seton Hall University 1984 — 1988
BS, Chemistry, Physics, Cum Laude
Elizabeth Gallagher's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2008 - October 2010
Job Director Global Logistics at Fisher Clinical Services
Industry Pharmaceuticals
Experience
Fisher Clinical Services October 2012 - Present
Daiichi Sankyo November 2010 - October 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - October 2010
Centocor March 2002 - June 2008
Clinical Systems Inc 1999 - 2002
Johnson & Johnson, McNeil Consumer & Specialty Pharmaceuticals 1984 - 1999
Skills
Pharmaceutical Packaging, Clinical Trials, Pharmaceutical Industry, Clinical Research, Lifesciences, Clinical Supplies, Logistics, Biotechnology, Validation, Supply Chain Management, FDA, Oncology, Technology Transfer, CAPA, GMP, SOP
Education
Saint Joseph's University
BA
Fisher Clinical Services October 2012 - Present
Daiichi Sankyo November 2010 - October 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - October 2010
Centocor March 2002 - June 2008
Clinical Systems Inc 1999 - 2002
Johnson & Johnson, McNeil Consumer & Specialty Pharmaceuticals 1984 - 1999
Skills
Pharmaceutical Packaging, Clinical Trials, Pharmaceutical Industry, Clinical Research, Lifesciences, Clinical Supplies, Logistics, Biotechnology, Validation, Supply Chain Management, FDA, Oncology, Technology Transfer, CAPA, GMP, SOP
Education
Saint Joseph's University
BA
Marie Danielle Vil-Young Marie Danielle Vil-Young's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2001 - 2009
Job Owner at À Votre Service Events®, LLC
Industry Events Services
Experience
À Votre Service Events®, LLC August 2008 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2001 - 2009
Skills
Event Planning, Entertainment, Product Launch, Wedding Planning, Fashion Shows, Meeting Planning, Galas, Event Management, Fundraising, Conferences, Trade Shows, Management, Social Media Marketing, Small Business, Social Networking, Corporate Events, Leadership, Parties, Marketing, Weddings, Entrepreneurship
Education
Saint John's University 2002 — 2004
Master in Science
Stony Brook University
Bachelor in Science, Biochemistry
À Votre Service Events®, LLC August 2008 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2001 - 2009
Skills
Event Planning, Entertainment, Product Launch, Wedding Planning, Fashion Shows, Meeting Planning, Galas, Event Management, Fundraising, Conferences, Trade Shows, Management, Social Media Marketing, Small Business, Social Networking, Corporate Events, Leadership, Parties, Marketing, Weddings, Entrepreneurship
Education
Saint John's University 2002 — 2004
Master in Science
Stony Brook University
Bachelor in Science, Biochemistry
Geri Bardelli Geri Bardelli's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience July 2010 - May 2013
Job Associate Director, Clinical Programs at Alexion Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Alexion Pharmaceuticals, Inc. September 2014 - Present
Novartis Vaccines and Diagnostics May 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2010 - May 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - July 2010
CombinatoRx Inc. October 2008 - March 2009
CombinatoRx Inc. October 2007 - October 2008
Averion International 2001 - 2007
Averion International July 2004 - September 2006
Averion International February 2003 - July 2004
Averion International April 2001 - February 2003
Skills
Oncology, Biotechnology, Clinical Trials, Clinical Monitoring, EDC, CTMS, CRO, GCP, Pharmaceutical Industry
Education
Suffolk University
MBA, Health/Health Care Administration/Management
University of New Hampshire 1989 — 1993
Bachelor of Science (B.S.), Medical Laboratory Science
Merrimack High School 1985 — 1989
Alexion Pharmaceuticals, Inc. September 2014 - Present
Novartis Vaccines and Diagnostics May 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2010 - May 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2009 - July 2010
CombinatoRx Inc. October 2008 - March 2009
CombinatoRx Inc. October 2007 - October 2008
Averion International 2001 - 2007
Averion International July 2004 - September 2006
Averion International February 2003 - July 2004
Averion International April 2001 - February 2003
Skills
Oncology, Biotechnology, Clinical Trials, Clinical Monitoring, EDC, CTMS, CRO, GCP, Pharmaceutical Industry
Education
Suffolk University
MBA, Health/Health Care Administration/Management
University of New Hampshire 1989 — 1993
Bachelor of Science (B.S.), Medical Laboratory Science
Merrimack High School 1985 — 1989
Naila Tahir Naila Tahir's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2005 - March 2006
Job Owner/Photographer at Once Upon a Noor Photography
Industry Arts and Crafts
Experience
Once Upon a Noor Photography November 2012 - Present
Nur al Lail Collections August 2011 - Present
Self-employed July 2011 - Present
Pfizer May 2006 - July 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2005 - March 2006
Skills
Change Management, Art, Photoshop, Painting, Drawing, Photography, Digital Photography, Teaching
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2004
Bachelor of Arts (BA), History & Middle Eastern Studies
Once Upon a Noor Photography November 2012 - Present
Nur al Lail Collections August 2011 - Present
Self-employed July 2011 - Present
Pfizer May 2006 - July 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2005 - March 2006
Skills
Change Management, Art, Photoshop, Painting, Drawing, Photography, Digital Photography, Teaching
Education
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2004
Bachelor of Arts (BA), History & Middle Eastern Studies
Stephen T. Orosz, Jr. Stephen T. Orosz, Jr.'s ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2009 - March 2015
Job Drug Product Manufacturing and Facilities Lead at Spark Therapeutics, Inc.
Industry Biotechnology
Experience
Spark Therapeutics, Inc. March 2015 - Present
New Jersey Institute of Technology January 2002 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2009 - March 2015
Select Medical Corporation June 2008 - January 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2002 - April 2009
Skills
Validation, GMP, Technology Transfer, Biotechnology, Pharmaceutical Industry, FDA, SOP, 21 CFR Part 11, CAPA, Change Control
Education
Rutgers, The State University of New Jersey-New Brunswick
PhD, Pharmaceutical Sciences
Spark Therapeutics, Inc. March 2015 - Present
New Jersey Institute of Technology January 2002 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2009 - March 2015
Select Medical Corporation June 2008 - January 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2002 - April 2009
Skills
Validation, GMP, Technology Transfer, Biotechnology, Pharmaceutical Industry, FDA, SOP, 21 CFR Part 11, CAPA, Change Control
Education
Rutgers, The State University of New Jersey-New Brunswick
PhD, Pharmaceutical Sciences
Peter Borzilleri Peter Borzilleri's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2008 - 2009
Job VP of Finance and Principal Financial Officer at Super EnterprisesUSA, Inc.
Industry Biotechnology
Experience
Super Enterprises-USA, Inc. May 2013 - Present
Anvil Knitwear January 2011 - December 2012
Anvil Knitwear August 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - 2009
ImClone Systems Incorporated 2007 - 2008
ImClone Systems Incorporated 2002 - 2007
ADP 2001 - 2002
United Rentals 1999 - 2001
Mannesmann Corporation 1994 - 1999
Volvo Penta 1988 - 1994
Skills
Accounting, Sarbanes-Oxley Act, Internal Controls, Cost Accounting, Mergers, Due Diligence, Auditing, Internal Audit, SEC, Strategic Financial..., Risk Assessment, Acquisition Integration, Corporate Tax Planning, Cash Management, Financial Reporting, Financial Analysis, Compliance
Education
State University of New York College at Oswego 1974 — 1978
BS
Super Enterprises-USA, Inc. May 2013 - Present
Anvil Knitwear January 2011 - December 2012
Anvil Knitwear August 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - 2009
ImClone Systems Incorporated 2007 - 2008
ImClone Systems Incorporated 2002 - 2007
ADP 2001 - 2002
United Rentals 1999 - 2001
Mannesmann Corporation 1994 - 1999
Volvo Penta 1988 - 1994
Skills
Accounting, Sarbanes-Oxley Act, Internal Controls, Cost Accounting, Mergers, Due Diligence, Auditing, Internal Audit, SEC, Strategic Financial..., Risk Assessment, Acquisition Integration, Corporate Tax Planning, Cash Management, Financial Reporting, Financial Analysis, Compliance
Education
State University of New York College at Oswego 1974 — 1978
BS
Joseph Chebli, PharmD, MA Joseph Chebli, PharmD, MA's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience July 2004 - June 2005
Job Medical Director/Managing Member at JC Rx Consultant
Industry Hospital & Health Care
Experience
JC RX Consulting, LLC May 2014 - Present
Felician College January 2012 - 2015
Johnson & Johnson March 2013 - May 2014
Bristol-Myers Squibb July 2012 - February 2013
Pharma-Care, Inc 2002 - February 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2004 - June 2005
Pfizer August 2003 - August 2004
Skills
Clinical Research, Pharmacovigilance, Pharmaceutical Industry, Medical Writing, Healthcare, Pharmacists, Diabetes, Oncology, Clinical Development, Pharmacology, Regulatory Submissions, Medication Therapy..., Regulatory Affairs, Clinical Trials, Pharmacy, Infectious Diseases, Patient Safety, Hospitals, Religious Studies, Systematic Theology, Bioethics, Medical Needs...
Education
Shenandoah University 2011 — 2013
PharmD, Doctorate in Clinical Pharmacy
Seton Hall University 2006 — 2011
MA Theology, Systematic Theology
Saint John's University 1989 — 1995
B.S Pharmacy, Pharmacy
JC RX Consulting, LLC May 2014 - Present
Felician College January 2012 - 2015
Johnson & Johnson March 2013 - May 2014
Bristol-Myers Squibb July 2012 - February 2013
Pharma-Care, Inc 2002 - February 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2004 - June 2005
Pfizer August 2003 - August 2004
Skills
Clinical Research, Pharmacovigilance, Pharmaceutical Industry, Medical Writing, Healthcare, Pharmacists, Diabetes, Oncology, Clinical Development, Pharmacology, Regulatory Submissions, Medication Therapy..., Regulatory Affairs, Clinical Trials, Pharmacy, Infectious Diseases, Patient Safety, Hospitals, Religious Studies, Systematic Theology, Bioethics, Medical Needs...
Education
Shenandoah University 2011 — 2013
PharmD, Doctorate in Clinical Pharmacy
Seton Hall University 2006 — 2011
MA Theology, Systematic Theology
Saint John's University 1989 — 1995
B.S Pharmacy, Pharmacy
Jennifer Sootkoos's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2009 - Present
Job Project Coordinator at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2009 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2007 - March 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2001 - June 2007
Skills
Biotechnology, Pharmaceutical Industry, Oncology, Clinical Development, Sop, Project Management, FDA, Lifesciences, GMP
Education
Seton Hall University 1997 — 2001
Bachelor of Science (B.S.), Marketing
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2009 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2007 - March 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2001 - June 2007
Skills
Biotechnology, Pharmaceutical Industry, Oncology, Clinical Development, Sop, Project Management, FDA, Lifesciences, GMP
Education
Seton Hall University 1997 — 2001
Bachelor of Science (B.S.), Marketing
Christopher Gent Christopher Gent's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2005 - 2006
Job
Industry Pharmaceuticals
Experience
Quintiles 2014 - Present
Shire Pharmaceuticals 2010 - 2014
Monsanto 2006 - 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2005 - 2006
Schering-Plough Research Institute 2003 - 2005
Wyeth 2002 - 2003
Pharmacia 1999 - 2002
US Navy Reserve 1992 - 2000
Skills
Operational Excellence, Lean Sigma, Green Belt, Quality Assurance, Auditing, Risk Management, 21 CFR Part 11, Computer System..., GAMP, Quality System, Validation, GMP, Six Sigma, FDA, R&D, GLP, Regulatory Affairs, GxP, Sop, Quality Auditing, Change Control, Cross-functional Team..., Pharmaceutical Industry, SOP
Education
Villanova University 2012 — 2012
Masters Certificate, Organizational Leadership
Webster University 2001 — 2003
MA, Computer Science
Saint Louis University 1996 — 2000
BS, Computer Science
Quintiles 2014 - Present
Shire Pharmaceuticals 2010 - 2014
Monsanto 2006 - 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2005 - 2006
Schering-Plough Research Institute 2003 - 2005
Wyeth 2002 - 2003
Pharmacia 1999 - 2002
US Navy Reserve 1992 - 2000
Skills
Operational Excellence, Lean Sigma, Green Belt, Quality Assurance, Auditing, Risk Management, 21 CFR Part 11, Computer System..., GAMP, Quality System, Validation, GMP, Six Sigma, FDA, R&D, GLP, Regulatory Affairs, GxP, Sop, Quality Auditing, Change Control, Cross-functional Team..., Pharmaceutical Industry, SOP
Education
Villanova University 2012 — 2012
Masters Certificate, Organizational Leadership
Webster University 2001 — 2003
MA, Computer Science
Saint Louis University 1996 — 2000
BS, Computer Science
Lauren (Lori) Kovatch Long Lauren (Lori) Kovatch Long's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2001 - 2006
Job Associate Director Quality Assurance at Merck
Industry Biotechnology
Experience
Merck November 2014 - Present
Merck August 2011 - Present
Kentucky BioProcessing, LLC February 2008 - August 2011
Bella Vista Equestrian Center 2006 - August 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2001 - 2006
ImClone Systems Inc. 2001 - 2005
Education
Seton Hall University 2002 — 2005
Masters, Microbiology
Sweet Briar College 1997 — 2001
BS, Biology
Merck November 2014 - Present
Merck August 2011 - Present
Kentucky BioProcessing, LLC February 2008 - August 2011
Bella Vista Equestrian Center 2006 - August 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2001 - 2006
ImClone Systems Inc. 2001 - 2005
Education
Seton Hall University 2002 — 2005
Masters, Microbiology
Sweet Briar College 1997 — 2001
BS, Biology
Jason Dow Jason Dow's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience December 2007 - August 2012
Job Experienced Quality Systems and Information Technology Leader in the Biotech/Pharma Industry
Industry Biotechnology
Experience
Regeneron Pharmaceuticals, Inc. April 2014 - Present
Teva Pharmaceuticals October 2013 - April 2014
Teva Pharmaceutical Industries Ltd. August 2012 - October 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - August 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2003 - December 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2002 - May 2003
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2001 - December 2002
McNeil Nutritionals 1999 - 2001
Skills
Visio, Microsoft Office, Business Process..., Process Mapping, Computer System..., Software Validation, Full SDLC, Compliance Audits, 21 CFR Part 11, Annex 11, Software Quality..., Quality Systems, GAMP, ITIL, Validation, GxP, GMP, FDA, cGMP, Word, MS Project, Excel, Document Management, Business Analysis, Quality Assurance, Pharmaceuticals, LIMS, Cross-functional Team..., Trackwise, Software Documentation, Management, CAPA, Auditing, Process Improvement, GCP, GLP, SDLC, Regulatory Requirements, Lifesciences, Change Management, Change Control, Pharmaceutical Industry, Quality System, Technology Transfer, Testing, Sop, V&V, Documentum, Business Process, Biotechnology
Education
Strayer University 2005 — 2008
Bachelor's Degree, Management Information Systems, General
Regeneron Pharmaceuticals, Inc. April 2014 - Present
Teva Pharmaceuticals October 2013 - April 2014
Teva Pharmaceutical Industries Ltd. August 2012 - October 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - August 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2003 - December 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2002 - May 2003
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2001 - December 2002
McNeil Nutritionals 1999 - 2001
Skills
Visio, Microsoft Office, Business Process..., Process Mapping, Computer System..., Software Validation, Full SDLC, Compliance Audits, 21 CFR Part 11, Annex 11, Software Quality..., Quality Systems, GAMP, ITIL, Validation, GxP, GMP, FDA, cGMP, Word, MS Project, Excel, Document Management, Business Analysis, Quality Assurance, Pharmaceuticals, LIMS, Cross-functional Team..., Trackwise, Software Documentation, Management, CAPA, Auditing, Process Improvement, GCP, GLP, SDLC, Regulatory Requirements, Lifesciences, Change Management, Change Control, Pharmaceutical Industry, Quality System, Technology Transfer, Testing, Sop, V&V, Documentum, Business Process, Biotechnology
Education
Strayer University 2005 — 2008
Bachelor's Degree, Management Information Systems, General
Alison Chalker Alison Chalker's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2010 - August 2012
Job PMO Therapeutic Area Leader, Neuroscience at Janssen, Pharmaceutical Companies of Johnson and Johnson
Industry Pharmaceuticals
Experience
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2013 - Present
Merck August 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - August 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2009 - April 2010
Shire March 2005 - June 2009
GSK March 2001 - March 2005
GSK October 1990 - March 2005
The University of Edinburgh 1989 - 1990
University of Edinburgh 1986 - 1989
Bristol University 1983 - 1986
Skills
Organizational..., Drug Development, Program Management, Organizational..., Department Management, Leading Change, Cross-functional Team..., Regulatory Affairs, Operational Excellence, Training Staff, Project Portfolio..., Getting The Job Done, Change Initiatives, Organisational..., Quality Management, Portfolio Strategy, Staff Development, Staff Management, Strategic Planning, Business Alliances, Due Diligence, Management, Clinical Development, Change Control, Biochemistry, Biotechnology, FDA, 21 CFR Part 11, Oncology, Biologics, CTMS, Biopharmaceuticals, Neurology, Regulatory Submissions, Neuroscience, CRO, GCP, Drug Discovery, Biomarkers, Technology Transfer, Vaccines, Clinical Trials, Sop, Team Leadership, Therapeutic Areas, Medical Affairs, SOP
Education
University of Pennsylvania - The Wharton School 2008 — 2008
n/a
University of Pennsylvania - The Wharton School 2003 — 2003
n/a
Temple University 2001 — 2002
Certificate
The University of Edinburgh 1986 — 1990
PhD
University of Bristol 1983 — 1986
BSc
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2013 - Present
Merck August 2012 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - August 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2009 - April 2010
Shire March 2005 - June 2009
GSK March 2001 - March 2005
GSK October 1990 - March 2005
The University of Edinburgh 1989 - 1990
University of Edinburgh 1986 - 1989
Bristol University 1983 - 1986
Skills
Organizational..., Drug Development, Program Management, Organizational..., Department Management, Leading Change, Cross-functional Team..., Regulatory Affairs, Operational Excellence, Training Staff, Project Portfolio..., Getting The Job Done, Change Initiatives, Organisational..., Quality Management, Portfolio Strategy, Staff Development, Staff Management, Strategic Planning, Business Alliances, Due Diligence, Management, Clinical Development, Change Control, Biochemistry, Biotechnology, FDA, 21 CFR Part 11, Oncology, Biologics, CTMS, Biopharmaceuticals, Neurology, Regulatory Submissions, Neuroscience, CRO, GCP, Drug Discovery, Biomarkers, Technology Transfer, Vaccines, Clinical Trials, Sop, Team Leadership, Therapeutic Areas, Medical Affairs, SOP
Education
University of Pennsylvania - The Wharton School 2008 — 2008
n/a
University of Pennsylvania - The Wharton School 2003 — 2003
n/a
Temple University 2001 — 2002
Certificate
The University of Edinburgh 1986 — 1990
PhD
University of Bristol 1983 — 1986
BSc
Rutu Patel Rutu Patel's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2010 - May 2012
Job Site Manager at Novo Nordisk
Industry Pharmaceuticals
Experience
Novo Nordisk July 2013 - Present
Forest Laboratories May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2010 - May 2012
Skills
Pharmaceutical Industry, Oncology, Biotechnology, Clinical Trials, Clinical Development, CRO, Regulatory Affairs, GCP, Medical Devices, Lifesciences, CTMS, GMP, SOP, FDA, Clinical Research, Drug Development, Regulatory Submissions, Management
Education
Rutgers University-New Brunswick 2010 — 2016
Master’s Degree, Public Health
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2005
BA, Biology, Pyschology
Novo Nordisk July 2013 - Present
Forest Laboratories May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2010 - May 2012
Skills
Pharmaceutical Industry, Oncology, Biotechnology, Clinical Trials, Clinical Development, CRO, Regulatory Affairs, GCP, Medical Devices, Lifesciences, CTMS, GMP, SOP, FDA, Clinical Research, Drug Development, Regulatory Submissions, Management
Education
Rutgers University-New Brunswick 2010 — 2016
Master’s Degree, Public Health
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2005
BA, Biology, Pyschology
Shruti Shah, MBS Shruti Shah, MBS's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2011 - August 2011
Job Scientist III at Oncobiologics Inc.
Industry Biotechnology
Experience
Oncobiologics Inc. September 2014 - Present
Oncobiologics Inc. January 2014 - August 2014
Oncobiologics Inc. March 2012 - December 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - August 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2010 - August 2010
Skills
Biacore, ELISA, SDS-PAGE, Biochemistry, Protein Chemistry, Assay Development, Cell, Antibodies, Cell Culture, Regulatory Affairs, CTD, Bioassay, HPLC, Transfection, Cellular Assays, TLC, Antigen, RNA isolation, DNA extraction, recombinant DNA..., Plasmid Isolation, Molecular Cloning, Vector Cloning, LIMS, SoftMax Pro, Empower, Intellectual Property, Electronic Lab Notebooks, Biostatistics, Sop, GLP, PCR, RT-PCR, Microscopy, Process Qualification, R, Hypothesis Testing, Statistical Tools, Market Analysis, Leadership, FDA, GLPs, Project Management, Market Research, Thomson Reuters..., GMP
Education
Rutgers University 2011 — 2013
Masters in Business and Science (MBS), Biotechnology and Genomics, GPA: 3.8
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2012
Bachelors, Biotechnology, GPA - 3.9
Oncobiologics Inc. September 2014 - Present
Oncobiologics Inc. January 2014 - August 2014
Oncobiologics Inc. March 2012 - December 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - August 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2010 - August 2010
Skills
Biacore, ELISA, SDS-PAGE, Biochemistry, Protein Chemistry, Assay Development, Cell, Antibodies, Cell Culture, Regulatory Affairs, CTD, Bioassay, HPLC, Transfection, Cellular Assays, TLC, Antigen, RNA isolation, DNA extraction, recombinant DNA..., Plasmid Isolation, Molecular Cloning, Vector Cloning, LIMS, SoftMax Pro, Empower, Intellectual Property, Electronic Lab Notebooks, Biostatistics, Sop, GLP, PCR, RT-PCR, Microscopy, Process Qualification, R, Hypothesis Testing, Statistical Tools, Market Analysis, Leadership, FDA, GLPs, Project Management, Market Research, Thomson Reuters..., GMP
Education
Rutgers University 2011 — 2013
Masters in Business and Science (MBS), Biotechnology and Genomics, GPA: 3.8
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2012
Bachelors, Biotechnology, GPA - 3.9
christopher klem christopher klem's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2004 - Present
Job Director of BioServices, ImClone Systems, a wholly owned subsidiary of Eli Lilly
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2004 - Present
Skills
Technology Transfer, cGMP, Biopharmaceuticals, GMP, Validation, FDA
Education
Rutgers University-New Brunswick 1987 — 1992
B.A., Economics
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2004 - Present
Skills
Technology Transfer, cGMP, Biopharmaceuticals, GMP, Validation, FDA
Education
Rutgers University-New Brunswick 1987 — 1992
B.A., Economics
Greg Mayes Greg Mayes's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2005 - October 2010
Job EVP and Chief Operating Officer, Advaxis, Inc.
Industry Biotechnology
Experience
Advaxis, Inc. October 2013 - Present
Dendreon January 2013 - October 2013
Unigene Laboratories, Inc. September 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2005 - October 2010
Hiway Theatre 2005 - 2007
AstraZeneca January 2001 - January 2005
Morgan, Lewis & Bockius LLP January 1998 - January 2001
Klehr Harrison Harvey Branzburg & Ellers September 1995 - January 1998
Skills
Legal Writing, V&V, Business Planning, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Licensing, FDA, Lifesciences, Technology Transfer, Intellectual Property, Oncology, Clinical Development, Medical Devices, Patents, Clinical Trials, Commercialization, Mergers, Due Diligence, Biopharmaceuticals, Joint Ventures, Corporate Governance, Regulatory Requirements, Out-licensing, R&D agreements, Development Agreements, Marketing Agreements, Management Of Outside..., Corporate Transactional, Pharmaceutics
Education
Temple University - James E. Beasley School of Law 1992 — 1995
J.D. magna cum laude
Syracuse University 1987 — 1991
B.S. Cum Laude
Advaxis, Inc. October 2013 - Present
Dendreon January 2013 - October 2013
Unigene Laboratories, Inc. September 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2005 - October 2010
Hiway Theatre 2005 - 2007
AstraZeneca January 2001 - January 2005
Morgan, Lewis & Bockius LLP January 1998 - January 2001
Klehr Harrison Harvey Branzburg & Ellers September 1995 - January 1998
Skills
Legal Writing, V&V, Business Planning, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Licensing, FDA, Lifesciences, Technology Transfer, Intellectual Property, Oncology, Clinical Development, Medical Devices, Patents, Clinical Trials, Commercialization, Mergers, Due Diligence, Biopharmaceuticals, Joint Ventures, Corporate Governance, Regulatory Requirements, Out-licensing, R&D agreements, Development Agreements, Marketing Agreements, Management Of Outside..., Corporate Transactional, Pharmaceutics
Education
Temple University - James E. Beasley School of Law 1992 — 1995
J.D. magna cum laude
Syracuse University 1987 — 1991
B.S. Cum Laude
Marie Parrish Marie Parrish's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience December 2012 - Present
Job Associate Director, Technical Services/ Mfg Sciences, CMC Regulatory Support Eli Lilly and Company
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2012 - Present
sanofi-aventis January 2007 - March 2012
sanofi-aventis January 2005 - December 2006
Aventis July 2004 - December 2004
Aventis March 2001 - June 2004
Pfizer June 2000 - March 2001
warner lambert 1992 - 2001
Warner Lambert/Parke Davis June 1992 - June 2000
Skills
Regulatory Submissions, FDA, Formulation Development, Analytics, International..., Pharmaceuticals, Documentum, e-CTD, Pharmaceutical..., MAA, NDA, CTA, IND, Regulations, Pharmaceutical Industry, Formulation, Lifesciences, HPLC, Chromatography, GLP, CMC, Product Development, Validation, Sop, GMP, Pharmaceutics, Drug Development, R&D, Medicinal Chemistry, Technology Transfer, Organic Chemistry, Regulatory Affairs, Drug Discovery, Biopharmaceuticals, Clinical Development, LIMS
Education
Rutgers, The State University of New Jersey-New Brunswick
Ph.D, Pharmaceutical Analysis
University of the Sciences in Philadelphia
B.S., Chemistry
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2012 - Present
sanofi-aventis January 2007 - March 2012
sanofi-aventis January 2005 - December 2006
Aventis July 2004 - December 2004
Aventis March 2001 - June 2004
Pfizer June 2000 - March 2001
warner lambert 1992 - 2001
Warner Lambert/Parke Davis June 1992 - June 2000
Skills
Regulatory Submissions, FDA, Formulation Development, Analytics, International..., Pharmaceuticals, Documentum, e-CTD, Pharmaceutical..., MAA, NDA, CTA, IND, Regulations, Pharmaceutical Industry, Formulation, Lifesciences, HPLC, Chromatography, GLP, CMC, Product Development, Validation, Sop, GMP, Pharmaceutics, Drug Development, R&D, Medicinal Chemistry, Technology Transfer, Organic Chemistry, Regulatory Affairs, Drug Discovery, Biopharmaceuticals, Clinical Development, LIMS
Education
Rutgers, The State University of New Jersey-New Brunswick
Ph.D, Pharmaceutical Analysis
University of the Sciences in Philadelphia
B.S., Chemistry
Khaled Rifai Khaled Rifai's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2002 - February 2003
Job Managing Consultant at PharmEng Technology
Industry Information Technology and Services
Experience
PharmEng Technology June 2005 - Present
Alcon, a Novartis company January 2009 - April 2014
CIBA Vision July 2005 - December 2008
Apotex Inc. March 2005 - June 2005
Alfa Laval October 2001 - March 2005
Eli Lilly Italia March 2003 - March 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2002 - February 2003
Pfizer March 2002 - November 2002
Skills
Project Management, Quality Management, Computer System..., SDLC, Software Quality..., Quality Assurance, Validation, Compliance, 21 CFR Part 11, GxP, cGMP practices, Process Automation, Process Control, Control Engineering, Control Panel Design, PLC Programming, P&ID, Telecommunications, FDA, Quality System, Manufacturing, SOP
Education
Ryerson University 1997 — 2001
Bachelor of Engineering (B.Eng.), Computer and Electrical
PharmEng Technology June 2005 - Present
Alcon, a Novartis company January 2009 - April 2014
CIBA Vision July 2005 - December 2008
Apotex Inc. March 2005 - June 2005
Alfa Laval October 2001 - March 2005
Eli Lilly Italia March 2003 - March 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2002 - February 2003
Pfizer March 2002 - November 2002
Skills
Project Management, Quality Management, Computer System..., SDLC, Software Quality..., Quality Assurance, Validation, Compliance, 21 CFR Part 11, GxP, cGMP practices, Process Automation, Process Control, Control Engineering, Control Panel Design, PLC Programming, P&ID, Telecommunications, FDA, Quality System, Manufacturing, SOP
Education
Ryerson University 1997 — 2001
Bachelor of Engineering (B.Eng.), Computer and Electrical
Denis Scheper Denis Scheper's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2007 - March 2012
Job Director, Project Management
Industry Pharmaceuticals
Experience
Aprecia Pharmaceuticals March 2015 - Present
Aprecia Pharmaceuticals March 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - March 2012
ImClone Systems May 2005 - January 2007
ImClone Systems April 2004 - May 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2003 - April 2004
BASF July 2000 - April 2003
Skills
GMP, Validation, HVAC, Process Engineering, cGMP, SOP, Biotechnology, Pharmaceuticals, Process Optimization, Process Validation, Cross-functional Team..., FDA, Change Control, Sop, Regulatory Affairs, Biopharmaceuticals, Engineering, 21 CFR Part 11, Process Simulation, LIMS, GAMP, Technology Transfer, R&D, Pharmaceutical Industry, CAPA, GxP, V&V, Facilities Engineering, Quality System, Computer System..., GLP
Education
Stevens Institute of Technology 1995 — 2000
Aprecia Pharmaceuticals March 2015 - Present
Aprecia Pharmaceuticals March 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - March 2012
ImClone Systems May 2005 - January 2007
ImClone Systems April 2004 - May 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2003 - April 2004
BASF July 2000 - April 2003
Skills
GMP, Validation, HVAC, Process Engineering, cGMP, SOP, Biotechnology, Pharmaceuticals, Process Optimization, Process Validation, Cross-functional Team..., FDA, Change Control, Sop, Regulatory Affairs, Biopharmaceuticals, Engineering, 21 CFR Part 11, Process Simulation, LIMS, GAMP, Technology Transfer, R&D, Pharmaceutical Industry, CAPA, GxP, V&V, Facilities Engineering, Quality System, Computer System..., GLP
Education
Stevens Institute of Technology 1995 — 2000
Scott Vaspory's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2006 - July 2011
Job Core Team, MFG Startup / Process Engineer at Protein Sciences Corporation
Industry Biotechnology
Experience
Protein Sciences Corporation July 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - July 2011
Rutgers, Cook College April 2004 - May 2006
GlobespanVirata May 2002 - August 2002
Skills
GMP, PCR, GLP, Cell Culture, Biotechnology, Microbiology, Sop, Laboratory, Gas Chromatography, Process Engineering, Technology Transfer, Bioreactor, Vaccines, SDS-PAGE, Six Sigma, Aseptic Technique, Pharmaceutical Industry, Fermentation, R, CAPA, Western Blotting, Aseptic Processing, Change Control, LIMS, Manufacturing, Protein Expression, Biopharmaceuticals, FDA, Protein Chemistry, Purification
Education
Rutgers University-New Brunswick 2002 — 2006
B.S., Biotechnology and Biochemistry
Protein Sciences Corporation July 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - July 2011
Rutgers, Cook College April 2004 - May 2006
GlobespanVirata May 2002 - August 2002
Skills
GMP, PCR, GLP, Cell Culture, Biotechnology, Microbiology, Sop, Laboratory, Gas Chromatography, Process Engineering, Technology Transfer, Bioreactor, Vaccines, SDS-PAGE, Six Sigma, Aseptic Technique, Pharmaceutical Industry, Fermentation, R, CAPA, Western Blotting, Aseptic Processing, Change Control, LIMS, Manufacturing, Protein Expression, Biopharmaceuticals, FDA, Protein Chemistry, Purification
Education
Rutgers University-New Brunswick 2002 — 2006
B.S., Biotechnology and Biochemistry
Marie Bolognini Marie Bolognini's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2009 - August 2010
Job Senior Chemist at L'Oréal
Industry Biotechnology
Experience
L'Oréal December 2014 - Present
L'Oreal July 2014 - December 2014
L'Oréal December 2012 - July 2014
L'Oréal January 2012 - December 2012
Rutgers University September 2010 - January 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - August 2010
Chromocell Corporation August 2007 - September 2009
US Army May 2007 - January 2009
Skills
Cell Culture, Biotechnology, Molecular Biology, PCR, Microbiology, DNA sequencing, Genomics, Gel Electrophoresis, ELISA, HPLC
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2012
Masters of Business and Science, Biotechnology and Genomics
Rutgers University-New Brunswick 2007 — 2009
Bachelors of Science, Microbial Biotechnology
L'Oréal December 2014 - Present
L'Oreal July 2014 - December 2014
L'Oréal December 2012 - July 2014
L'Oréal January 2012 - December 2012
Rutgers University September 2010 - January 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - August 2010
Chromocell Corporation August 2007 - September 2009
US Army May 2007 - January 2009
Skills
Cell Culture, Biotechnology, Molecular Biology, PCR, Microbiology, DNA sequencing, Genomics, Gel Electrophoresis, ELISA, HPLC
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2012
Masters of Business and Science, Biotechnology and Genomics
Rutgers University-New Brunswick 2007 — 2009
Bachelors of Science, Microbial Biotechnology
Lindsay Laudal Lindsay Laudal's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2008 - October 2008
Job Clinical Research Associate II at Avid Radiopharmaceuticals
Industry Pharmaceuticals
Experience
Avid Radiopharmaceuticals October 2013 - Present
Dettera Restaurant and Wine Bar September 2012 - September 2013
Novavax September 2011 - August 2012
Human Genome Sciences November 2008 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2008 - October 2008
GlaxoSmithKline June 2005 - April 2008
Skills
GCP, CRO, Clinical Trials, CTMS, EDC, ICH-GCP
Education
Saint Joseph's University 2002 — 2005
Biology
Avid Radiopharmaceuticals October 2013 - Present
Dettera Restaurant and Wine Bar September 2012 - September 2013
Novavax September 2011 - August 2012
Human Genome Sciences November 2008 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2008 - October 2008
GlaxoSmithKline June 2005 - April 2008
Skills
GCP, CRO, Clinical Trials, CTMS, EDC, ICH-GCP
Education
Saint Joseph's University 2002 — 2005
Biology
Michael Boonie's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2008 - October 2012
Job
Industry Pharmaceuticals
Experience
Pharmica Consulting LLC October 2013 - Present
Merck (via TayganPoint Consulting) October 2011 - October 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - October 2012
Merck Research Labs December 2002 - September 2008
Merck July 1997 - December 2002
Merck July 1994 - July 1997
ZIFF Technologies/Coretech July 1993 - July 1994
BETZ Industrial June 1991 - July 1993
Personal Computer Learning Centers of America, Inc July 1986 - June 1991
Skills
Training, Adobe Acrobat, 21 CFR Part 11, Reference Manager, Documentum, FDA, Pharmaceutical Industry, Document Management, Computer System..., Sop, Validation, Software Documentation, Change Control, Education Software, Lifesciences, VBA, SharePoint, Business Intelligence, GxP, Testing, Databases, Access, SOP, Life Sciences
Education
Temple University 1985 — 1987
M.Ed., Educational Technology
Temple University 1981 — 1985
B.A., Music Education
Pharmica Consulting LLC October 2013 - Present
Merck (via TayganPoint Consulting) October 2011 - October 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - October 2012
Merck Research Labs December 2002 - September 2008
Merck July 1997 - December 2002
Merck July 1994 - July 1997
ZIFF Technologies/Coretech July 1993 - July 1994
BETZ Industrial June 1991 - July 1993
Personal Computer Learning Centers of America, Inc July 1986 - June 1991
Skills
Training, Adobe Acrobat, 21 CFR Part 11, Reference Manager, Documentum, FDA, Pharmaceutical Industry, Document Management, Computer System..., Sop, Validation, Software Documentation, Change Control, Education Software, Lifesciences, VBA, SharePoint, Business Intelligence, GxP, Testing, Databases, Access, SOP, Life Sciences
Education
Temple University 1985 — 1987
M.Ed., Educational Technology
Temple University 1981 — 1985
B.A., Music Education
Cindy Benedict's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2003 - 2007
Job Senior Manager, Global Corporate Strategy & Business Development at Amneal Pharmaceuticals
Industry Pharmaceuticals
Experience
Amneal Pharmaceuticals April 2015 - Present
Sandoz November 2011 - April 2015
CorePharma LLC December 2008 - November 2011
BearingPoint 2007 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2003 - 2007
Skills
Lifesciences, Licensing, Business Development, Negotiation, Management, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Medical Devices, Technology Transfer, GMP, Validation, Clinical Trials, Biopharmaceuticals, Cross-functional Team..., Sop, Oncology, Healthcare, FDA, Strategic Planning, Generic Drugs, Business Alliance..., Strategy, Pharmaceutics, Business Analysis, Business Intelligence, Drug Development, Generic Programming, New Business Development, Quality Assurance, Business Strategy, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark
MBA
University of Scranton
BS
Amneal Pharmaceuticals April 2015 - Present
Sandoz November 2011 - April 2015
CorePharma LLC December 2008 - November 2011
BearingPoint 2007 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2003 - 2007
Skills
Lifesciences, Licensing, Business Development, Negotiation, Management, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Medical Devices, Technology Transfer, GMP, Validation, Clinical Trials, Biopharmaceuticals, Cross-functional Team..., Sop, Oncology, Healthcare, FDA, Strategic Planning, Generic Drugs, Business Alliance..., Strategy, Pharmaceutics, Business Analysis, Business Intelligence, Drug Development, Generic Programming, New Business Development, Quality Assurance, Business Strategy, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark
MBA
University of Scranton
BS
Monika Gibson's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2011 - April 2012
Job QC Microbiology Supervisor at Eli Lilly and Company
Industry Biotechnology
Experience
Eli Lilly and Company May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - March 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2006 - August 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2005 - March 2006
Skills
LIMS, Microbiology, GMP, Sop, Validation, Environmental Monitoring, Biopharmaceuticals, CAPA, Biotechnology, 21 CFR Part 11, FDA, GxP, Aseptic Processing, Trackwise, SOP
Education
Seton Hall University 2007 — 2010
MS, Microbiology
Rutgers, The State University of New Jersey-Newark 2001 — 2005
BA, Biology
Eli Lilly and Company May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - April 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - March 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2006 - August 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2005 - March 2006
Skills
LIMS, Microbiology, GMP, Sop, Validation, Environmental Monitoring, Biopharmaceuticals, CAPA, Biotechnology, 21 CFR Part 11, FDA, GxP, Aseptic Processing, Trackwise, SOP
Education
Seton Hall University 2007 — 2010
MS, Microbiology
Rutgers, The State University of New Jersey-Newark 2001 — 2005
BA, Biology
Haejin Kim's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2011 - March 2013
Job Submission Manager
Industry Pharmaceuticals
Experience
CSC February 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2011 - March 2013
Image Solutions, Inc. January 2008 - January 2011
Image Solutions, Inc. January 2005 - January 2008
Skills
eCTD, Regulatory Operations, Regulatory Submissions, Regulatory Affairs, NDA, Pharmaceutical Industry, 21 CFR Part 11, FDA, Regulatory Requirements
Education
Rutgers University-New Brunswick 1999 — 2003
CSC February 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2011 - March 2013
Image Solutions, Inc. January 2008 - January 2011
Image Solutions, Inc. January 2005 - January 2008
Skills
eCTD, Regulatory Operations, Regulatory Submissions, Regulatory Affairs, NDA, Pharmaceutical Industry, 21 CFR Part 11, FDA, Regulatory Requirements
Education
Rutgers University-New Brunswick 1999 — 2003
Jim Huber's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2007 - August 2013
Job Director, Project and Alliance Management at Advaxis, Inc.
Industry Biotechnology
Experience
Advaxis, Inc. June 2015 - Present
Drais Pharmaceuticals August 2013 - June 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - August 2013
ImClone Systems February 1996 - May 2007
Medarex 1994 - 1996
Regeneron Pharmaceuticals 1993 - 1994
Skills
GLP, Sop, Drug Development, Biopharmaceuticals, Biotechnology, Project Management, Monoclonal Antibodies, Project Portfolio..., Process Improvement, Immunology, Clinical Data Management, CTMS, Clinical Trials, Lifesciences, Clinical Development, Assay Development, Change Control, Cell, ICH-GCP, Cell Biology, GxP, Oncology, Drug Discovery, Pharmaceutical Industry, FDA, 21 CFR Part 11, R&D, CRO, Genomics, Regulatory Submissions, Clinical Monitoring, Validation, Biochemistry, Cell Culture, Technology Transfer, ELISA, Quality System, Clinical Research, GMP, Regulatory Affairs, EDC, Regulatory Requirements, Commercialization, Data Management, Cross-functional Team..., GCP, Molecular Biology, IND, Therapeutic Areas
Education
Rutgers University-New Brunswick 1990 — 1993
bs, biochemistry
Advaxis, Inc. June 2015 - Present
Drais Pharmaceuticals August 2013 - June 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - August 2013
ImClone Systems February 1996 - May 2007
Medarex 1994 - 1996
Regeneron Pharmaceuticals 1993 - 1994
Skills
GLP, Sop, Drug Development, Biopharmaceuticals, Biotechnology, Project Management, Monoclonal Antibodies, Project Portfolio..., Process Improvement, Immunology, Clinical Data Management, CTMS, Clinical Trials, Lifesciences, Clinical Development, Assay Development, Change Control, Cell, ICH-GCP, Cell Biology, GxP, Oncology, Drug Discovery, Pharmaceutical Industry, FDA, 21 CFR Part 11, R&D, CRO, Genomics, Regulatory Submissions, Clinical Monitoring, Validation, Biochemistry, Cell Culture, Technology Transfer, ELISA, Quality System, Clinical Research, GMP, Regulatory Affairs, EDC, Regulatory Requirements, Commercialization, Data Management, Cross-functional Team..., GCP, Molecular Biology, IND, Therapeutic Areas
Education
Rutgers University-New Brunswick 1990 — 1993
bs, biochemistry
Ernie Bognar's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2000 - 2003
Job Biotechnology Strategy and Operations Executive
Industry Biotechnology
Experience
Dendreon 2013 - Present
Dendreon 2009 - 2012
Dendreon 2006 - 2009
AppTec Laboratory Services 2003 - 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2000 - 2003
Baxter 1995 - 2000
Skills
Validation, Biopharmaceuticals, Operations Management, Biotechnology, GMP, Management, Lifesciences, FDA, CAPA, GLP, Aseptic Processing, Sop, Cross-functional Team..., Pharmaceutical Industry, Technology Transfer, Oncology, Change Control, V&V, Life Sciences, SOP, Manufacturing, Cell Culture, Plant Start Up, Manufacturing..., Organizational..., Quality System
Education
W. Alton Jones Cell Science Center, Lake Placid, New York 1982 — 1982
Cell Biology Certificate, Cell Biology
State University of New York College at Plattsburgh 1977 — 1982
Bachelor of Science in In Vitro Cell Biology, In Vitro Cell Biology
Dendreon 2013 - Present
Dendreon 2009 - 2012
Dendreon 2006 - 2009
AppTec Laboratory Services 2003 - 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2000 - 2003
Baxter 1995 - 2000
Skills
Validation, Biopharmaceuticals, Operations Management, Biotechnology, GMP, Management, Lifesciences, FDA, CAPA, GLP, Aseptic Processing, Sop, Cross-functional Team..., Pharmaceutical Industry, Technology Transfer, Oncology, Change Control, V&V, Life Sciences, SOP, Manufacturing, Cell Culture, Plant Start Up, Manufacturing..., Organizational..., Quality System
Education
W. Alton Jones Cell Science Center, Lake Placid, New York 1982 — 1982
Cell Biology Certificate, Cell Biology
State University of New York College at Plattsburgh 1977 — 1982
Bachelor of Science in In Vitro Cell Biology, In Vitro Cell Biology
Joe Grosso's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2009 - February 2014
Job Clinical Development Liason at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company February 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - February 2014
HGS April 2007 - April 2009
Medarex November 2003 - April 2007
Skills
Oncology, Clinical Trials, Clinical Development, CRO, GCP, CTMS, Clinical Monitoring, Pharmaceutical Industry, ICH-GCP, Drug Development, EDC, Sop, Clinical Operations, Biotechnology, Biopharmaceuticals, Regulatory Affairs, Pharmacovigilance, Therapeutic Areas, FDA, Vaccines, Infectious Diseases, Immunology, Medical Affairs, Neurology, Hematology, IND, Lifesciences, Regulatory Requirements, Cardiology, Rheumatology, Diabetes
Education
Rutgers University-New Brunswick 2001 — 2003
MBA, Concentration: Pharmaceutical Management
Rutgers University-New Brunswick 1996 — 2001
BS, Public Health with MInor in Biology
Eli Lilly and Company February 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - February 2014
HGS April 2007 - April 2009
Medarex November 2003 - April 2007
Skills
Oncology, Clinical Trials, Clinical Development, CRO, GCP, CTMS, Clinical Monitoring, Pharmaceutical Industry, ICH-GCP, Drug Development, EDC, Sop, Clinical Operations, Biotechnology, Biopharmaceuticals, Regulatory Affairs, Pharmacovigilance, Therapeutic Areas, FDA, Vaccines, Infectious Diseases, Immunology, Medical Affairs, Neurology, Hematology, IND, Lifesciences, Regulatory Requirements, Cardiology, Rheumatology, Diabetes
Education
Rutgers University-New Brunswick 2001 — 2003
MBA, Concentration: Pharmaceutical Management
Rutgers University-New Brunswick 1996 — 2001
BS, Public Health with MInor in Biology
Guangliang Greg Pan's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2004 - 2007
Job Biologics Outsourced Development and Manufacturing at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences 2014 - Present
Eli Lilly and Company 2007 - 2014
Novartis Pharmaceutical Corporation 2007 - 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2004 - 2007
Johnson & Johnson Consumer Products 2003 - 2004
Skills
Formulation, Peptides, GMP, Drug Development, Monoclonal Antibodies, Drug Discovery, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Assay Development, GLP, Purification
Education
The University of Georgia
Ph.D., Pharmaceutics / Biochemistry and Molecular Biology
University of North Texas
M.S., Microbiology
Shandong University
B.S., Bioengineering
Gilead Sciences 2014 - Present
Eli Lilly and Company 2007 - 2014
Novartis Pharmaceutical Corporation 2007 - 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2004 - 2007
Johnson & Johnson Consumer Products 2003 - 2004
Skills
Formulation, Peptides, GMP, Drug Development, Monoclonal Antibodies, Drug Discovery, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Assay Development, GLP, Purification
Education
The University of Georgia
Ph.D., Pharmaceutics / Biochemistry and Molecular Biology
University of North Texas
M.S., Microbiology
Shandong University
B.S., Bioengineering
Amy Chess's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2012 - August 2014
Job Research Associate at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company July 2006 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2012 - August 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - December 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - June 2008
Medicia Corporation 1999 - 2006
Skills
LIMS, CAPA, GMP, Aseptic Processing, GLP, Sop, 21 CFR Part 11, Validation, Environmental Monitoring, FDA, Aseptic Technique, Change Control, Biopharmaceuticals, Trackwise, GxP, Microbiology, SOP
Education
Richard Stockton College of New Jersey 1994 — 1999
Bachelor of Science (BS), Biology, General
Eli Lilly and Company July 2006 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2012 - August 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - December 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - June 2008
Medicia Corporation 1999 - 2006
Skills
LIMS, CAPA, GMP, Aseptic Processing, GLP, Sop, 21 CFR Part 11, Validation, Environmental Monitoring, FDA, Aseptic Technique, Change Control, Biopharmaceuticals, Trackwise, GxP, Microbiology, SOP
Education
Richard Stockton College of New Jersey 1994 — 1999
Bachelor of Science (BS), Biology, General
Anne DeMartino's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2005 - August 2007
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Mina Kang's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2013 - April 2014
Job Learning Technologies Specialist Tiffany & Co.
Industry Design
Experience
Tiffany & Co. April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2013 - April 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - September 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - January 2007
Skills
E-Learning, Project Management, Instructional Design, Technical Training, Software Documentation, Graphic Design, Microsoft Office, Training, SharePoint, Data Analysis, PowerPoint, Change Management, Program Management, Research, System Administration, Visio
Education
Rutgers University-New Brunswick 2001 — 2006
BS, Biology / Psychology
Langevin
Instructional Design
Rutgers University-New Brunswick
Mini MBA: Biopharma Innovation Certificate Program
Tiffany & Co. April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2013 - April 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - September 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - January 2007
Skills
E-Learning, Project Management, Instructional Design, Technical Training, Software Documentation, Graphic Design, Microsoft Office, Training, SharePoint, Data Analysis, PowerPoint, Change Management, Program Management, Research, System Administration, Visio
Education
Rutgers University-New Brunswick 2001 — 2006
BS, Biology / Psychology
Langevin
Instructional Design
Rutgers University-New Brunswick
Mini MBA: Biopharma Innovation Certificate Program
Joseph Delfs's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2009 - November 2011
Job Manager, Change Control and Compliance at BristolMyers Squibb, Hopewell, New Jersey
Industry Biotechnology
Experience
Bristol-Myers Squibb November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - November 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2004 - January 2009
Integrated Project Services, Incorporated June 2002 - May 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 1999 - June 2002
R&D Circuits, Incorporated September 1998 - June 1999
Manhattan College June 1998 - September 1998
Skills
GMP, Compliance, Change Management, Change Control, Validation, Quality Assurance, Quality Management, Biopharmaceuticals, Quality System, Aseptic Processing, Sop, CAPA, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, GxP, Computer System..., LIMS, Chromatography, Cleaning Validation, GLP, Trackwise, Technology Transfer, Regulatory Affairs
Education
Stevens Institute of Technology 2007 — 2010
MS, Management
Stevens Institute of Technology 1994 — 1998
BE, Chemical Engineering
Bristol-Myers Squibb November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - November 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2004 - January 2009
Integrated Project Services, Incorporated June 2002 - May 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 1999 - June 2002
R&D Circuits, Incorporated September 1998 - June 1999
Manhattan College June 1998 - September 1998
Skills
GMP, Compliance, Change Management, Change Control, Validation, Quality Assurance, Quality Management, Biopharmaceuticals, Quality System, Aseptic Processing, Sop, CAPA, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, GxP, Computer System..., LIMS, Chromatography, Cleaning Validation, GLP, Trackwise, Technology Transfer, Regulatory Affairs
Education
Stevens Institute of Technology 2007 — 2010
MS, Management
Stevens Institute of Technology 1994 — 1998
BE, Chemical Engineering
Elizabeth Wescott's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2005 - September 2007
Job QA Compliance Senior Specialist at ImClone Systems
Industry Biotechnology
Experience
ImClone Systems September 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - September 2007
Wyeth 2004 - 2005
Skills
Quality Assurance, Validation, CAPA, Manufacturing, GMP, Pharmaceutical Industry, Six Sigma, Sop, Biopharmaceuticals, 21 CFR Part 11, CQA, Computer System..., FDA
Education
Stevens Institute of Technology 2007 — 2010
Master of Science, Pharmaceutical Manufacturing
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor of Science, Environmental Policy, Institutions & Behavior
ImClone Systems September 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - September 2007
Wyeth 2004 - 2005
Skills
Quality Assurance, Validation, CAPA, Manufacturing, GMP, Pharmaceutical Industry, Six Sigma, Sop, Biopharmaceuticals, 21 CFR Part 11, CQA, Computer System..., FDA
Education
Stevens Institute of Technology 2007 — 2010
Master of Science, Pharmaceutical Manufacturing
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor of Science, Environmental Policy, Institutions & Behavior
Michelle McLaughlin's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience February 2010 - May 2010
Job Bioengineer I at Celgene Cellular Therapeutics
Industry Biotechnology
Experience
Celgene Cellular Therapeutics December 2012 - Present
Celgene Cellular Therapeutics May 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2010 - May 2010
The Wistar Institute September 2008 - December 2009
Celgene Cellular Therapeutics May 2009 - August 2009
The Wistar Institute January 2009 - May 2009
ImClone Systems March 2008 - August 2008
ImClone Systems May 2007 - March 2008
Rutgers University February 2006 - December 2006
Skills
Cell, Cell Culture, HPLC, Molecular Biology, Biochemistry, Flow Cytometry, Assay Development, Purification, Protein Expression
Education
University of Pennsylvania 2008 — 2009
M.S., Molecular Biotechnology
Rutgers University-New Brunswick 2003 — 2007
B.S., Biotechnology
Celgene Cellular Therapeutics December 2012 - Present
Celgene Cellular Therapeutics May 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2010 - May 2010
The Wistar Institute September 2008 - December 2009
Celgene Cellular Therapeutics May 2009 - August 2009
The Wistar Institute January 2009 - May 2009
ImClone Systems March 2008 - August 2008
ImClone Systems May 2007 - March 2008
Rutgers University February 2006 - December 2006
Skills
Cell, Cell Culture, HPLC, Molecular Biology, Biochemistry, Flow Cytometry, Assay Development, Purification, Protein Expression
Education
University of Pennsylvania 2008 — 2009
M.S., Molecular Biotechnology
Rutgers University-New Brunswick 2003 — 2007
B.S., Biotechnology
Courtney Veeck's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience February 2012 - Present
Job at
Industry Research
Experience
Paragon Bioservices, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
ImClone Systems October 2008 - February 2012
Celgene 2002 - 2007
Skills
Quality Control, GMP, Sop, 21 CFR Part 11, Biotechnology, FDA, LIMS, Laboratory, Microbiology, Pharmaceutical Industry, SOP
Education
Susquehanna University 2004 — 2008
BS, Biology
Paragon Bioservices, Inc. April 2015 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - Present
ImClone Systems October 2008 - February 2012
Celgene 2002 - 2007
Skills
Quality Control, GMP, Sop, 21 CFR Part 11, Biotechnology, FDA, LIMS, Laboratory, Microbiology, Pharmaceutical Industry, SOP
Education
Susquehanna University 2004 — 2008
BS, Biology
Richard Seipert's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience December 2008 - January 2012
Job Scientist at Genentech
Industry Biotechnology
Experience
Genentech January 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2008 - January 2012
University of California, Davis September 2004 - December 2008
AnaSpec January 2004 - June 2004
SJSU January 2002 - May 2004
Water Pollution Control Facility June 2001 - October 2003
Skills
Method Development, HPLC, Mass Spectrometry, Protein Chemistry, Microbiology, Bioanalysis, Peptides, Characterization, Sop, Pharmaceutical Industry, Analytical Chemistry, LC-MS, Chemistry, UV/Vis, Chromatography, Biochemistry
Education
University of California, Davis 2004 — 2008
Ph.D, Analytical Chemistry
San Jose State University 1999 — 2004
BS, Chemistry
Genentech January 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2008 - January 2012
University of California, Davis September 2004 - December 2008
AnaSpec January 2004 - June 2004
SJSU January 2002 - May 2004
Water Pollution Control Facility June 2001 - October 2003
Skills
Method Development, HPLC, Mass Spectrometry, Protein Chemistry, Microbiology, Bioanalysis, Peptides, Characterization, Sop, Pharmaceutical Industry, Analytical Chemistry, LC-MS, Chemistry, UV/Vis, Chromatography, Biochemistry
Education
University of California, Davis 2004 — 2008
Ph.D, Analytical Chemistry
San Jose State University 1999 — 2004
BS, Chemistry
Nathalie Hawse's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2009 - September 2010
Job Registered Nurse at Hackensack University Medical Center/ Pharmacovigilance Associate at BristolMyers Squibb
Industry Hospital & Health Care
Experience
Bristol-Myers Squibb January 2013 - Present
Hackensack University Medical Center May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - September 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - October 2009
Shore Memorial Hospital January 2007 - June 2007
Shore Memorial Hospital September 2006 - December 2006
Skills
Oncology, Hematology, Stem Cell Transplant, Bone Marrow..., Chemotherapy, Biotherapeutics, Pharmacovigilance, Clinical Trials, Nursing, Pharmaceuticals, Sop, Clinical Research, Clinical, FDA, Healthcare, Data Entry, Quality Assurance, Documentation, Medicine, BLS, Software Documentation, Pharmaceutical Industry, Medical Devices, Drug Safety
Education
The University of Medicine and Dentistry of NJ 2010 — 2011
BSN, Nursing
Richard Stockton College of New Jersey 2003 — 2007
B.S, Public Health, Healthcare Administration
Bristol-Myers Squibb January 2013 - Present
Hackensack University Medical Center May 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - September 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - October 2009
Shore Memorial Hospital January 2007 - June 2007
Shore Memorial Hospital September 2006 - December 2006
Skills
Oncology, Hematology, Stem Cell Transplant, Bone Marrow..., Chemotherapy, Biotherapeutics, Pharmacovigilance, Clinical Trials, Nursing, Pharmaceuticals, Sop, Clinical Research, Clinical, FDA, Healthcare, Data Entry, Quality Assurance, Documentation, Medicine, BLS, Software Documentation, Pharmaceutical Industry, Medical Devices, Drug Safety
Education
The University of Medicine and Dentistry of NJ 2010 — 2011
BSN, Nursing
Richard Stockton College of New Jersey 2003 — 2007
B.S, Public Health, Healthcare Administration
Dilip Raghunathan's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2010 - June 2012
Job
Industry Pharmaceuticals
Experience
Accenture January 2014 - Present
MannKind Corporation February 2012 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2010 - June 2012
Amgen March 2010 - August 2010
MannKind Corporation 2008 - 2010
Kendle International 2007 - 2008
Various 2004 - 2007
Skills
CRO, CDISC, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Biostatistics, SDTM, SAS, Data Management, 21 CFR Part 11, SAS programming, GCP, Pharmaceutical Industry, Validation, Clinical Research, Biotechnology, ADAMS, define xml, Oncology Clinical..., Diabetes, Statistical Programming, Oncology, CTMS, Clinical Development, ICH-GCP, Regulatory Submissions, CRF design, FDA, Computer System..., Drug Development, Lifesciences, Sop, Therapeutic Areas, Inform, Protocol, Life Sciences, SAS Programming, SOP
Education
New York University - Leonard N. Stern School of Business 2011 — 2013
Masters, Business and Information Systems
Rutgers University-New Brunswick
Bachelors, Biomedical Engineering
Accenture January 2014 - Present
MannKind Corporation February 2012 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2010 - June 2012
Amgen March 2010 - August 2010
MannKind Corporation 2008 - 2010
Kendle International 2007 - 2008
Various 2004 - 2007
Skills
CRO, CDISC, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Biostatistics, SDTM, SAS, Data Management, 21 CFR Part 11, SAS programming, GCP, Pharmaceutical Industry, Validation, Clinical Research, Biotechnology, ADAMS, define xml, Oncology Clinical..., Diabetes, Statistical Programming, Oncology, CTMS, Clinical Development, ICH-GCP, Regulatory Submissions, CRF design, FDA, Computer System..., Drug Development, Lifesciences, Sop, Therapeutic Areas, Inform, Protocol, Life Sciences, SAS Programming, SOP
Education
New York University - Leonard N. Stern School of Business 2011 — 2013
Masters, Business and Information Systems
Rutgers University-New Brunswick
Bachelors, Biomedical Engineering
Chuck Mellyn's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2011 - Present
Job Director SAP and BioPharm Ops Systems at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems Incorporated August 2001 - Present
Skills
SAP, GMP, Validation, Biotechnology, Computer System..., Pharmaceutical Industry, 21 CFR Part 11, Sop, FDA, ITIL, Oncology, Lifesciences, Change Control, Technology Transfer, Lotus Notes, LIMS
Education
University at Albany, SUNY 2002 — 2004
MBA, Information Systems
State University of New York College at Oneonta 1975 — 1976
BS, Geology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems Incorporated August 2001 - Present
Skills
SAP, GMP, Validation, Biotechnology, Computer System..., Pharmaceutical Industry, 21 CFR Part 11, Sop, FDA, ITIL, Oncology, Lifesciences, Change Control, Technology Transfer, Lotus Notes, LIMS
Education
University at Albany, SUNY 2002 — 2004
MBA, Information Systems
State University of New York College at Oneonta 1975 — 1976
BS, Geology
Richard Mejasich's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2012 - Present
Job Associate Vice President Oncology Global Marketing
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2008 - September 2012
GPC-Biotech, Inc. July 2007 - December 2007
Sanofi-Aventis Oncology (formerly Aventis Oncology) February 2005 - July 2007
Aventis Oncology (formerly Rhone-Poulenc Rorer Oncology) April 1999 - February 2005
Rhone-Poulenc Rorer Oncology March 1996 - April 1999
National Specialty Services (NSS) January 1994 - March 1996
Syntex Laboratories September 1992 - December 1993
US Army December 1988 - August 1992
Education
Shippensburg University of Pennsylvania 1984 — 1988
Bachelor's Degree, Biology/Biological Sciences, General
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2008 - September 2012
GPC-Biotech, Inc. July 2007 - December 2007
Sanofi-Aventis Oncology (formerly Aventis Oncology) February 2005 - July 2007
Aventis Oncology (formerly Rhone-Poulenc Rorer Oncology) April 1999 - February 2005
Rhone-Poulenc Rorer Oncology March 1996 - April 1999
National Specialty Services (NSS) January 1994 - March 1996
Syntex Laboratories September 1992 - December 1993
US Army December 1988 - August 1992
Education
Shippensburg University of Pennsylvania 1984 — 1988
Bachelor's Degree, Biology/Biological Sciences, General
Monica Lin's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2011 - August 2013
Job Learning Content Services Manager at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company September 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - June 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2004 - July 2006
Immunomedics 2000 - 2004
Skills
Project Planning, Project Implementation, Project Coordination, Problem Solving, Problem Analysis, Decision Making, Decision Analysis, Leadership Development, Team Leadership, Training & Development, Organizational..., Technical Training, Training Delivery, Training Skills, Team Management, Grant Application, Program Management, GMP, Quality Systems, Managerial Experience, Chinese, Learning Management, Performance Management, Mentoring, Bilingual, Quality System, Project Management, Training, Management, Sop, GxP, Employee Training, FDA, 21 CFR Part 11, Quality Assurance, CAPA, Validation, Pharmaceutical Industry, Computer System..., Clinical Trials, Regulatory Affairs, GLP, Change Control, Instructional Design, Process Improvement, Leadership, Clinical Development, Technology Transfer, CRO, GCP
Education
Rutgers School of Business - Camden 2011 — 2013
MBA, Professional MBA
Rutgers, The State University of New Jersey-Newark 2001 — 2003
MS, Biology
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
BS, Biochemistry
Eli Lilly and Company September 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2007 - June 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - December 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2004 - July 2006
Immunomedics 2000 - 2004
Skills
Project Planning, Project Implementation, Project Coordination, Problem Solving, Problem Analysis, Decision Making, Decision Analysis, Leadership Development, Team Leadership, Training & Development, Organizational..., Technical Training, Training Delivery, Training Skills, Team Management, Grant Application, Program Management, GMP, Quality Systems, Managerial Experience, Chinese, Learning Management, Performance Management, Mentoring, Bilingual, Quality System, Project Management, Training, Management, Sop, GxP, Employee Training, FDA, 21 CFR Part 11, Quality Assurance, CAPA, Validation, Pharmaceutical Industry, Computer System..., Clinical Trials, Regulatory Affairs, GLP, Change Control, Instructional Design, Process Improvement, Leadership, Clinical Development, Technology Transfer, CRO, GCP
Education
Rutgers School of Business - Camden 2011 — 2013
MBA, Professional MBA
Rutgers, The State University of New Jersey-Newark 2001 — 2003
MS, Biology
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
BS, Biochemistry
Ryan Mould's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2010 - Present
Job Senior Associate, Formulation Development
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems August 2005 - May 2010
Skills
LIMS, GMP, Validation, Aseptic Technique, FDA, Biopharmaceuticals, HPLC, Biotechnology, GLP, SDS-PAGE, Formulation, ELISA, Sop, Quality Control, 21 CFR Part 11, Aseptic Processing, GxP, CAPA, Technology Transfer
Education
Rutgers University-New Brunswick 2000 — 2005
B.S., Biological Sciences
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems August 2005 - May 2010
Skills
LIMS, GMP, Validation, Aseptic Technique, FDA, Biopharmaceuticals, HPLC, Biotechnology, GLP, SDS-PAGE, Formulation, ELISA, Sop, Quality Control, 21 CFR Part 11, Aseptic Processing, GxP, CAPA, Technology Transfer
Education
Rutgers University-New Brunswick 2000 — 2005
B.S., Biological Sciences
Harini vasudevan's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience February 2011 - February 2012
Job Research Scientist at BristolMyers Squibb, Princeton, New Jersey
Industry Biotechnology
Experience
Bristol-Myers Squibb, Princeton, New Jersey February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2011 - February 2012
Schering-Plough April 2009 - June 2010
VaxInnate Corporation December 2008 - March 2009
Novo Nordisk December 2005 - September 2008
University Of Medicine and dentistry of NJ March 2003 - November 2005
Education
Rutgers University-New Brunswick 2000 — 2003
MS, Cell and Developmental Biology
Bristol-Myers Squibb, Princeton, New Jersey February 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company February 2011 - February 2012
Schering-Plough April 2009 - June 2010
VaxInnate Corporation December 2008 - March 2009
Novo Nordisk December 2005 - September 2008
University Of Medicine and dentistry of NJ March 2003 - November 2005
Education
Rutgers University-New Brunswick 2000 — 2003
MS, Cell and Developmental Biology
Colby Garber's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2007 - 2014
Job Works at Eli Lilly
Industry Biotechnology
Experience
Eli Lilly and Company 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2014
Neose Technologies 2000 - 2007
Skills
Biotechnology, Sop, GMP, Validation, FDA, Pharmaceutical Industry, Lifesciences, Technology Transfer, GLP, Regulatory Affairs, Biochemistry, Cell Culture, Quality System, ELISA, Process Improvement
Education
Shippensburg University of Pennsylvania 1997 — 1999
BS, Biology (Medical Technology conc.)
University of Pittsburgh 1994 — 1996
Eli Lilly and Company 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2007 - 2014
Neose Technologies 2000 - 2007
Skills
Biotechnology, Sop, GMP, Validation, FDA, Pharmaceutical Industry, Lifesciences, Technology Transfer, GLP, Regulatory Affairs, Biochemistry, Cell Culture, Quality System, ELISA, Process Improvement
Education
Shippensburg University of Pennsylvania 1997 — 1999
BS, Biology (Medical Technology conc.)
University of Pittsburgh 1994 — 1996
Lollia Mikic's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2009 - Present
Job Manager, Regulatory Applications at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2009 - Present
Alpharma Inc. 2008 - 2009
Akros Pharma Inc. 2006 - 2008
Bristol-Myers Squibb company 2004 - 2006
Elan Pharmaceuticals 2002 - 2004
Ceridian Benefits Services Inc 1996 - 2001
Robert Wood Johnson University Hospital 1995 - 1996
Education
Regulatory Affairs Professional Society 2008 — 2009
RAC-US, Regulatory Affairs Certification
Rutgers University-New Brunswick
BA, Biology
The Chubb Institute
Diploma, Web Development & Business Programming
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2009 - Present
Alpharma Inc. 2008 - 2009
Akros Pharma Inc. 2006 - 2008
Bristol-Myers Squibb company 2004 - 2006
Elan Pharmaceuticals 2002 - 2004
Ceridian Benefits Services Inc 1996 - 2001
Robert Wood Johnson University Hospital 1995 - 1996
Education
Regulatory Affairs Professional Society 2008 — 2009
RAC-US, Regulatory Affairs Certification
Rutgers University-New Brunswick
BA, Biology
The Chubb Institute
Diploma, Web Development & Business Programming
Jeannie Fritzen's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2007 - December 2010
Job Experienced Contracts Coordinator and Communications Manager
Industry Logistics and Supply Chain
Experience
TRAC Intermodal June 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2007 - December 2010
LORELEI STAFFING AGENCY April 2006 - September 2007
TODAY'S STAFFING September 2005 - April 2006
NATIONAL ASSOCIATION OF FLEET ADMINISTRATORS October 2000 - September 2005
NEW JERSEY SPORTS AND EXPOSITION AUTHORITY November 1998 - March 1999
Skills
Outlook, Contract Management, Newsletters, Editing, Social Media, Lotus Notes, Publications, Management, Marketing Communications, Microsoft Office, Microsoft Word
Education
Seton Hall University 1991 — 1999
BA, English
Seton Hall University
Bachelor of Arts, English; writing
TRAC Intermodal June 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2007 - December 2010
LORELEI STAFFING AGENCY April 2006 - September 2007
TODAY'S STAFFING September 2005 - April 2006
NATIONAL ASSOCIATION OF FLEET ADMINISTRATORS October 2000 - September 2005
NEW JERSEY SPORTS AND EXPOSITION AUTHORITY November 1998 - March 1999
Skills
Outlook, Contract Management, Newsletters, Editing, Social Media, Lotus Notes, Publications, Management, Marketing Communications, Microsoft Office, Microsoft Word
Education
Seton Hall University 1991 — 1999
BA, English
Seton Hall University
Bachelor of Arts, English; writing
Erika Varriale's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2011 - September 2011
Job wodFuel Regional Sales Rep / CFL1 Trainer / Diamond Leader Independent Distributor, It Works! Global
Industry Health, Wellness and Fitness
Experience
Down East CrossFit October 2014 - Present
wodFuel August 2014 - Present
It Works Global September 2011 - Present
E L Varriale Consulting LLC January 2012 - March 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - December 2010
ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company June 2004 - June 2010
Skills
Biotechnology, Leadership, Cross-functional Team..., Internal Audit, Process Improvement, Training, Strategy, Regulatory Affairs, Mergers & Acquisitions, Healthcare, Policy, Clinical Trials, Software Documentation, Pharmaceutical Industry
Education
Rutgers University-New Brunswick 2001 — 2004
B.A., Biological Science
Rutgers University-New Brunswick 2001 — 2004
Minor, Marine Science
Down East CrossFit October 2014 - Present
wodFuel August 2014 - Present
It Works Global September 2011 - Present
E L Varriale Consulting LLC January 2012 - March 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - September 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - December 2010
ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company June 2004 - June 2010
Skills
Biotechnology, Leadership, Cross-functional Team..., Internal Audit, Process Improvement, Training, Strategy, Regulatory Affairs, Mergers & Acquisitions, Healthcare, Policy, Clinical Trials, Software Documentation, Pharmaceutical Industry
Education
Rutgers University-New Brunswick 2001 — 2004
B.A., Biological Science
Rutgers University-New Brunswick 2001 — 2004
Minor, Marine Science
Mark Gigantone, MS, CCRA's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2006 - March 2009
Job Clinical Research Scientist at Novartis
Industry Pharmaceuticals
Experience
Novartis Pharmaceuticals: US Oncology June 2013 - Present
Warner Chilcott March 2009 - May 2013
Research Assist Inc. May 2008 - March 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - March 2009
Johnson & Johnson October 2005 - June 2006
Cardinal Health May 2005 - August 2005
Skills
Sop, Pharmaceutical Industry, Biotechnology, GMP, GCP, CTMS, Clinical Trials, CRO, EDC, Clinical Development, Oncology, FDA, Dermatology, Validation, Lifesciences, Clinical Research, Clinical Monitoring, Urology, Medical Devices, 21 CFR Part 11, Clinical Operations, Therapeutic Areas, Life Sciences, SOP
Education
Stevens Institute of Technology 2010 — 2012
MS, Project Management
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
BS, Biotechnology
Novartis Pharmaceuticals: US Oncology June 2013 - Present
Warner Chilcott March 2009 - May 2013
Research Assist Inc. May 2008 - March 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - March 2009
Johnson & Johnson October 2005 - June 2006
Cardinal Health May 2005 - August 2005
Skills
Sop, Pharmaceutical Industry, Biotechnology, GMP, GCP, CTMS, Clinical Trials, CRO, EDC, Clinical Development, Oncology, FDA, Dermatology, Validation, Lifesciences, Clinical Research, Clinical Monitoring, Urology, Medical Devices, 21 CFR Part 11, Clinical Operations, Therapeutic Areas, Life Sciences, SOP
Education
Stevens Institute of Technology 2010 — 2012
MS, Project Management
Rutgers, The State University of New Jersey-New Brunswick 2001 — 2005
BS, Biotechnology
Amy DeSanto's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2011 - November 2012
Job Scientist III at Patheon Biologics
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2015 - Present
Patheon Biologics October 2014 - July 2015
Gallus BioPharmaceuticals July 2014 - October 2014
Teva Pharmaceuticals March 2014 - July 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - November 2012
Johnson & Johnson December 2010 - May 2011
Laureate Pharma November 2004 - December 2010
Roche Molecular Systems 2003 - 2004
Zeus Scientific 2002 - 2003
New Jersey Department of Agriculture 1999 - 2002
Skills
Biotechnology, GMP, Protein Chemistry, ELISA, Technology Transfer, Purification, Chromatography, Lifesciences, Biopharmaceuticals, GLP, HPLC, Protein Purification, Life Sciences
Education
Rutgers University-New Brunswick 1998 — 2001
BS, Plant Science
Bristol-Myers Squibb August 2015 - Present
Patheon Biologics October 2014 - July 2015
Gallus BioPharmaceuticals July 2014 - October 2014
Teva Pharmaceuticals March 2014 - July 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2011 - November 2012
Johnson & Johnson December 2010 - May 2011
Laureate Pharma November 2004 - December 2010
Roche Molecular Systems 2003 - 2004
Zeus Scientific 2002 - 2003
New Jersey Department of Agriculture 1999 - 2002
Skills
Biotechnology, GMP, Protein Chemistry, ELISA, Technology Transfer, Purification, Chromatography, Lifesciences, Biopharmaceuticals, GLP, HPLC, Protein Purification, Life Sciences
Education
Rutgers University-New Brunswick 1998 — 2001
BS, Plant Science
Francisca Allotey's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2012 - January 2013
Job Clinical Trial Manager for Investigator Sponsored Trials
Industry Pharmaceuticals
Experience
Sanofi September 2014 - Present
Sanofi January 2013 - September 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - January 2013
Merck Sharp & Dohme June 2009 - December 2010
Schering-Plough Research Institute January 2008 - June 2009
Skills
Clinical Trials, CTMS, Pharmaceutical Industry, GCP, CRO, Oncology, Clinical Research, Sop, Regulatory Affairs, Clinical Development, ICH-GCP, Clinical Data Management, FDA, Clinical Monitoring, EDC, Infectious Diseases, eCTD, Pharmacovigilance, Protocol, Medical Writing, Clinical Operations, Drug Safety, SOP
Education
University of Medicine and Dentistry of New Jersey
MBS, Pharmacology and Bio-defense
Rutgers University
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
Sanofi September 2014 - Present
Sanofi January 2013 - September 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - January 2013
Merck Sharp & Dohme June 2009 - December 2010
Schering-Plough Research Institute January 2008 - June 2009
Skills
Clinical Trials, CTMS, Pharmaceutical Industry, GCP, CRO, Oncology, Clinical Research, Sop, Regulatory Affairs, Clinical Development, ICH-GCP, Clinical Data Management, FDA, Clinical Monitoring, EDC, Infectious Diseases, eCTD, Pharmacovigilance, Protocol, Medical Writing, Clinical Operations, Drug Safety, SOP
Education
University of Medicine and Dentistry of New Jersey
MBS, Pharmacology and Bio-defense
Rutgers University
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
Einav Leberknight's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2011 - Present
Job Director, Clinical Trials
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
Bristol-Myers Squibb, Princeton, New Jersey May 2010 - January 2011
Medarex March 2008 - April 2010
Medarex September 2006 - March 2008
Johnson & Johnson June 2003 - August 2006
Galderma December 2002 - June 2003
Galderma November 2000 - December 2002
Johnson & Johnson September 1999 - November 2000
Johnson & Johnson November 1998 - September 1999
Rutgers, The State University of New Jersey July 1997 - November 1998
Skills
Clinical Trials, GCP, Medical Affairs, Protocol, Clinical Operations, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Biotechnology, Clinical Development, GMP, Regulatory Submissions
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Biology and Anthropology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
Bristol-Myers Squibb, Princeton, New Jersey May 2010 - January 2011
Medarex March 2008 - April 2010
Medarex September 2006 - March 2008
Johnson & Johnson June 2003 - August 2006
Galderma December 2002 - June 2003
Galderma November 2000 - December 2002
Johnson & Johnson September 1999 - November 2000
Johnson & Johnson November 1998 - September 1999
Rutgers, The State University of New Jersey July 1997 - November 1998
Skills
Clinical Trials, GCP, Medical Affairs, Protocol, Clinical Operations, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Biotechnology, Clinical Development, GMP, Regulatory Submissions
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Biology and Anthropology
Michele Tenerelli's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2002 - 2006
Job Executive Director, Technical Operations Alliance Management at Celgene Corporation
Industry Pharmaceuticals
Experience
Celgene Corporation January 2014 - Present
Celgene July 2012 - December 2013
Celgene June 2008 - June 2012
Novartis 2006 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2002 - 2006
Pharmacia Corporation 1999 - 2002
PA Consulting Group 1996 - 1999
Skills
Pharmaceutical Industry, Oncology, Clinical Development, Clinical Trials, Biotechnology, Drug Development, Biopharmaceuticals, Regulatory Affairs, GCP, FDA, Regulatory Submissions, Therapeutic Areas, Lifesciences, Cross-functional Team...
Education
Thunderbird School of Global Management 1993 — 1994
MIM, International management
Rutgers, The State University of New Jersey-Newark
Celgene Corporation January 2014 - Present
Celgene July 2012 - December 2013
Celgene June 2008 - June 2012
Novartis 2006 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2002 - 2006
Pharmacia Corporation 1999 - 2002
PA Consulting Group 1996 - 1999
Skills
Pharmaceutical Industry, Oncology, Clinical Development, Clinical Trials, Biotechnology, Drug Development, Biopharmaceuticals, Regulatory Affairs, GCP, FDA, Regulatory Submissions, Therapeutic Areas, Lifesciences, Cross-functional Team...
Education
Thunderbird School of Global Management 1993 — 1994
MIM, International management
Rutgers, The State University of New Jersey-Newark
Patrick Falvey's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2010 - February 2015
Job Supervisor, Commercial Manufacturing – Cell Culture at Eli Lilly and Company
Industry Biotechnology
Experience
Eli Lilly and Company May 2015 - Present
Eli Lilly and Company March 2015 - May 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - February 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2006 - April 2010
Skills
Biotechnology, Clinical Research, FDA, V, Validation, Cell Culture
Education
Stevens Institute of Technology 2001 — 2006
Bachelor of Engineering, Biomedical Engineering
Eli Lilly and Company May 2015 - Present
Eli Lilly and Company March 2015 - May 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2010 - February 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2006 - April 2010
Skills
Biotechnology, Clinical Research, FDA, V, Validation, Cell Culture
Education
Stevens Institute of Technology 2001 — 2006
Bachelor of Engineering, Biomedical Engineering
Clifford Kwityn's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2008 - April 2009
Job Senior Manufacturing Scientist at Beckman Coulter
Industry Biotechnology
Experience
Beckman Coulter March 2013 - Present
Baylor College of Medicine September 2011 - March 2013
Chesapeake PERL October 2010 - March 2011
GWU 2011 - 2011
National Cancer Institute February 2009 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - April 2009
Skills
Biotechnology, Purification, Microbiology, Sop, Vaccines, Assay Development, Cell Culture, ELISA, Western Blotting, Microscopy, Molecular Biology, Lifesciences, Protein Expression, Protein Purification, SDS-PAGE, PCR, Cell Biology, Fluorescence Microscopy, Biochemistry, Protein Chemistry, GMP, Cell, Laboratory, recombinant DNA..., Immunoassays, Tissue Culture, Technology Transfer, Fermentation, Gel Electrophoresis
Education
The Johns Hopkins University 2011 — 2013
M.S., Biotechnology
Rutgers University-New Brunswick 2007 — 2008
B.S, Microbiology
Beckman Coulter March 2013 - Present
Baylor College of Medicine September 2011 - March 2013
Chesapeake PERL October 2010 - March 2011
GWU 2011 - 2011
National Cancer Institute February 2009 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - April 2009
Skills
Biotechnology, Purification, Microbiology, Sop, Vaccines, Assay Development, Cell Culture, ELISA, Western Blotting, Microscopy, Molecular Biology, Lifesciences, Protein Expression, Protein Purification, SDS-PAGE, PCR, Cell Biology, Fluorescence Microscopy, Biochemistry, Protein Chemistry, GMP, Cell, Laboratory, recombinant DNA..., Immunoassays, Tissue Culture, Technology Transfer, Fermentation, Gel Electrophoresis
Education
The Johns Hopkins University 2011 — 2013
M.S., Biotechnology
Rutgers University-New Brunswick 2007 — 2008
B.S, Microbiology
Kristina Offiong's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2012 - Present
Job Specialist, LMS Support at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - October 2012
Skills
Training, Project Management, Quality Assurance, Software Documentation
Education
Rutgers, The State University of New Jersey-Newark 2007 — 2009
BS, Management
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - October 2012
Skills
Training, Project Management, Quality Assurance, Software Documentation
Education
Rutgers, The State University of New Jersey-Newark 2007 — 2009
BS, Management
Galina Kurtser's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2000 - January 2007
Job Manager Analytical at Sanofi Pasteur
Industry Biotechnology
Experience
Sanofi Pasteur July 2011 - Present
Sanofi Pasteur January 2008 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2000 - January 2007
VI Technologies (VITEX) 1999 - 2001
Skills
Biotechnology, GMP, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Technology Transfer, GLP, Sop, Validation, Aseptic Processing, Quality Control, FDA, USP, Deviations, Analytical Method..., GxP, V&V, Change Control, SOP, Vaccines, 21 CFR Part 11, Cleaning Validation, HPLC
Education
Southern Federal University (former Rostov State University) 1985 — 1989
MS, Biochemistry
Sanofi Pasteur July 2011 - Present
Sanofi Pasteur January 2008 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2000 - January 2007
VI Technologies (VITEX) 1999 - 2001
Skills
Biotechnology, GMP, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Technology Transfer, GLP, Sop, Validation, Aseptic Processing, Quality Control, FDA, USP, Deviations, Analytical Method..., GxP, V&V, Change Control, SOP, Vaccines, 21 CFR Part 11, Cleaning Validation, HPLC
Education
Southern Federal University (former Rostov State University) 1985 — 1989
MS, Biochemistry
Guy Arco's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience September 2012 - Present
Job IT professional with extensive experience managing projects and development staffs.
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2012 - Present
Merck April 2011 - September 2011
Schering Plough (now Merck) 2000 - 2011
Dress Barn 2000 - 2000
Union Camp Corporation 1984 - 1999
Merrill Lynch Relocation 1978 - 1984
Phelps Dodge 1974 - 1978
Bank of New York 1972 - 1974
Skills
Project Planning, SDLC, Budgeting, Analysis, Cross-functional Team..., Validation, Pharmaceuticals, Pharmaceutical Industry, Budgets, Requirements Analysis, Business Analysis, Program Management, GxP, Project Management, Integration, Management, FDA, Business Process, Testing, SharePoint, Visio, MS Project, Databases, Software Development, Software Documentation, Project Portfolio..., Process Improvement, PMP, Vendor Management, IT Management, Quality Assurance, IT Strategy, Business Intelligence, 21 CFR Part 11, Computer System..., Change Control, ITIL, Six Sigma, PMO, Software Project..., Requirements Gathering, ERP, Information Technology, Business Process..., Resource Management, Data Management, Data Warehousing, Process Engineering, Business Requirements, Clinical Trials
Education
State University of New York at Delhi 1970 — 1972
Associate of Applied Science, Data Processing
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2012 - Present
Merck April 2011 - September 2011
Schering Plough (now Merck) 2000 - 2011
Dress Barn 2000 - 2000
Union Camp Corporation 1984 - 1999
Merrill Lynch Relocation 1978 - 1984
Phelps Dodge 1974 - 1978
Bank of New York 1972 - 1974
Skills
Project Planning, SDLC, Budgeting, Analysis, Cross-functional Team..., Validation, Pharmaceuticals, Pharmaceutical Industry, Budgets, Requirements Analysis, Business Analysis, Program Management, GxP, Project Management, Integration, Management, FDA, Business Process, Testing, SharePoint, Visio, MS Project, Databases, Software Development, Software Documentation, Project Portfolio..., Process Improvement, PMP, Vendor Management, IT Management, Quality Assurance, IT Strategy, Business Intelligence, 21 CFR Part 11, Computer System..., Change Control, ITIL, Six Sigma, PMO, Software Project..., Requirements Gathering, ERP, Information Technology, Business Process..., Resource Management, Data Management, Data Warehousing, Process Engineering, Business Requirements, Clinical Trials
Education
State University of New York at Delhi 1970 — 1972
Associate of Applied Science, Data Processing
Robert Kravitz's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2010 - September 2011
Job Global Head, Development Quality Performance Measurements at Novartis
Industry Pharmaceuticals
Experience
Novartis September 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - September 2011
Sanofi-Aventis 2006 - March 2010
Johnson & Johnson Gateway, LLC 2004 - 2006
Schering-Plough Research Institute 2001 - 2004
Taratec Development Corp 1998 - 2001
Block Drug Co 1993 - 1998
Environmental Testing & Certification Inc. 1990 - 1993
Skills
FDA, GMP, Validation, Quality Assurance, CAPA, 21 CFR Part 11, Sop, GLP, Computer System..., GxP, GCP, LIMS, Quality Management, Clinical Trials, Quality Auditing, Cross-functional Team..., Software Documentation, Change Control, Six Sigma, Quality Control, Medical Devices, Pharmaceutical Industry, Clinical Development, Pharmaceutics, Oncology, Drug Development, Life Sciences, CTMS, Clinical Research
Education
Stockton University 1986 — 1989
Bachelors, Chemistry
Chubb Institute of Computer Technology
Computer Programming
Novartis September 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - September 2011
Sanofi-Aventis 2006 - March 2010
Johnson & Johnson Gateway, LLC 2004 - 2006
Schering-Plough Research Institute 2001 - 2004
Taratec Development Corp 1998 - 2001
Block Drug Co 1993 - 1998
Environmental Testing & Certification Inc. 1990 - 1993
Skills
FDA, GMP, Validation, Quality Assurance, CAPA, 21 CFR Part 11, Sop, GLP, Computer System..., GxP, GCP, LIMS, Quality Management, Clinical Trials, Quality Auditing, Cross-functional Team..., Software Documentation, Change Control, Six Sigma, Quality Control, Medical Devices, Pharmaceutical Industry, Clinical Development, Pharmaceutics, Oncology, Drug Development, Life Sciences, CTMS, Clinical Research
Education
Stockton University 1986 — 1989
Bachelors, Chemistry
Chubb Institute of Computer Technology
Computer Programming
Minny Chang, RN BSN's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2006 - August 2006
Job Subject Matter Expert in Drug Safety and Medical Device
Industry Medical Devices
Experience
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
Payal Mehta's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2005 - December 2009
Job Regulatory Affairs Associate at Johnson & Johnson
Industry Biotechnology
Experience
Johnson & Johnson November 2013 - Present
Johnson & Johnson February 2011 - November 2013
NPS Pharmaceuticals 2010 - 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - December 2009
Skills
LIMS, GMP, GLP, Sop, Regulatory Affairs, Biotechnology, Quality Control, Validation, HPLC, FDA, Biopharmaceuticals, 21 CFR Part 11, CAPA, Lifesciences, ELISA, Chromatography, Technology Transfer, Cell Culture, Pharmaceutical Industry, Clinical Trials, Microbiology, SOP
Education
William Paterson University of New Jersey 2008 — 2010
MS, Biotechnology
Rutgers University-New Brunswick 2001 — 2005
BA, Biology
Johnson & Johnson November 2013 - Present
Johnson & Johnson February 2011 - November 2013
NPS Pharmaceuticals 2010 - 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2005 - December 2009
Skills
LIMS, GMP, GLP, Sop, Regulatory Affairs, Biotechnology, Quality Control, Validation, HPLC, FDA, Biopharmaceuticals, 21 CFR Part 11, CAPA, Lifesciences, ELISA, Chromatography, Technology Transfer, Cell Culture, Pharmaceutical Industry, Clinical Trials, Microbiology, SOP
Education
William Paterson University of New Jersey 2008 — 2010
MS, Biotechnology
Rutgers University-New Brunswick 2001 — 2005
BA, Biology
Kathleen Cyphers's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2006 - April 2011
Job Sales Associate, Weichert Realtors
Industry Biotechnology
Experience
Weichert Realtors, Flemington Office February 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - April 2011
A.M. Best Company August 1998 - January 2006
Skills
Human Resources, Employee Benefits, HRIS, Deferred Compensation, Training, Payroll, Management, Policy, Program Management, Benefits Administration, New Hire Orientations, Employee Relations, Performance Management, Talent Management, Personnel Management, Onboarding
Education
Southern New Hampshire University 2014 — 2015
Bachelor's Degree, Phychology with concentration in Mental Health
Thomas Edison State College 2006 — 2011
Psychology/ HR Management
Weichert Realtors, Flemington Office February 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - April 2011
A.M. Best Company August 1998 - January 2006
Skills
Human Resources, Employee Benefits, HRIS, Deferred Compensation, Training, Payroll, Management, Policy, Program Management, Benefits Administration, New Hire Orientations, Employee Relations, Performance Management, Talent Management, Personnel Management, Onboarding
Education
Southern New Hampshire University 2014 — 2015
Bachelor's Degree, Phychology with concentration in Mental Health
Thomas Edison State College 2006 — 2011
Psychology/ HR Management
Brigitte Noll's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2009 - August 2010
Job Technical Assistant/Grants&Contracts
Industry Biotechnology
Experience
inVentiv Health Clinical August 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2009 - August 2010
Bracco Diagnostics January 2008 - September 2009
Novo Nordisk Inc. September 2006 - December 2007
Bristol-Myers Squibb, Princeton, New Jersey 1988 - 2005
Skills
SAP, English, Excel, Word, German, Pharmacovigilance, Data Management, Documentation, Data Entry, SOP, Microsoft Office, Pharmaceuticals, Outlook, MedDRA, Sop
Education
Rutgers University-New Brunswick
BA, German Literature
inVentiv Health Clinical August 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2009 - August 2010
Bracco Diagnostics January 2008 - September 2009
Novo Nordisk Inc. September 2006 - December 2007
Bristol-Myers Squibb, Princeton, New Jersey 1988 - 2005
Skills
SAP, English, Excel, Word, German, Pharmacovigilance, Data Management, Documentation, Data Entry, SOP, Microsoft Office, Pharmaceuticals, Outlook, MedDRA, Sop
Education
Rutgers University-New Brunswick
BA, German Literature
Janelle Thompson's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2008 - April 2009
Job Sr. Clinical Tria Specialist eTMF Analyst, Business Support at Clinical Solutions Group (CSG, Inc.)
Industry Pharmaceuticals
Experience
Clinical Solutions Group (CSG, Inc.) June 2015 - Present
Sanofi August 2014 - June 2015
Novo Nordisk A/S June 2013 - May 2014
sanofi October 2011 - May 2013
sanofi-aventis June 2011 - October 2011
Johnson & Johnson PRD Global Enrollment Strategies Group April 2009 - April 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2008 - April 2009
J&J December 2006 - October 2008
GSK November 2005 - December 2006
Skills
Clinical Trials, CTMS, EDC, Clinical Research, Data Management, GCP, Protocol, Software Documentation, Therapeutic Areas, ICH-GCP, CRO, SOP, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-Newark 2011 — 2011
Certificate of Completion (36hrs), Essentials of Initiating Clinical Research
Anthem Institute 2010 — 2011
Medical Billing & Coding
Upsala College 1989 — 1993
BSW, Social Work
Clinical Solutions Group (CSG, Inc.) June 2015 - Present
Sanofi August 2014 - June 2015
Novo Nordisk A/S June 2013 - May 2014
sanofi October 2011 - May 2013
sanofi-aventis June 2011 - October 2011
Johnson & Johnson PRD Global Enrollment Strategies Group April 2009 - April 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2008 - April 2009
J&J December 2006 - October 2008
GSK November 2005 - December 2006
Skills
Clinical Trials, CTMS, EDC, Clinical Research, Data Management, GCP, Protocol, Software Documentation, Therapeutic Areas, ICH-GCP, CRO, SOP, Regulatory Affairs
Education
Rutgers, The State University of New Jersey-Newark 2011 — 2011
Certificate of Completion (36hrs), Essentials of Initiating Clinical Research
Anthem Institute 2010 — 2011
Medical Billing & Coding
Upsala College 1989 — 1993
BSW, Social Work
Nital Patel's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2008 - November 2009
Job Biotechnician at Merck
Industry Pharmaceuticals
Experience
Merck BiotechnicianMerckApril 2011 - December 2012
Merck February 2010 - April 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - November 2009
Skills
Biotechnology, Pharmaceutical Industry, GMP, HPLC, GLP, Chromatography, LIMS, Lifesciences, Cell Culture, Validation, Technology Transfer, Biopharmaceuticals, Cell, Drug Discovery, Protein Purification, Assay Development, Vaccines
Education
Temple University 2006 — 2008
Bachelor of Science, Biochemistry
Merck BiotechnicianMerckApril 2011 - December 2012
Merck February 2010 - April 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2008 - November 2009
Skills
Biotechnology, Pharmaceutical Industry, GMP, HPLC, GLP, Chromatography, LIMS, Lifesciences, Cell Culture, Validation, Technology Transfer, Biopharmaceuticals, Cell, Drug Discovery, Protein Purification, Assay Development, Vaccines
Education
Temple University 2006 — 2008
Bachelor of Science, Biochemistry
Evelyn D'Innocenzi's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2003 - 2005
Job
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2003 - 2005
Ethicon Inc. 1981 - 1987
Critikon Inc. 1977 - 1981
Education
Rutgers University 1974 — 1977
Bachelor's degree, Chemistry
The University of Rochester, NY 1973 — 1974
Chemistry
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2003 - 2005
Ethicon Inc. 1981 - 1987
Critikon Inc. 1977 - 1981
Education
Rutgers University 1974 — 1977
Bachelor's degree, Chemistry
The University of Rochester, NY 1973 — 1974
Chemistry
Katarzyna Case's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2008 - Present
Job Principal Associate at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2008 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Biochemistry and Molecular Biology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2008 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Biochemistry and Molecular Biology
Erik Corcoran's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2002 - June 2011
Job Principal Research Associate at Editas Medicine
Industry Biotechnology
Experience
Editas Medicine August 2015 - Present
H3 Biomedicine December 2012 - August 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2002 - June 2011
Microcide Pharmaceuticals 1998 - 2000
Skills
In Vivo, WinNonlin, Mouse Handling, Protocol Design, ELISA, xenograft model, PCR, Western Blotting, Plasma Processing, Cell Culture, Blood Collection, SOP authoring, Dosing, orthotopic models, Report Writing
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1995
Bachelor of Arts (BA), Biomedical Sciences, General
Editas Medicine August 2015 - Present
H3 Biomedicine December 2012 - August 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2002 - June 2011
Microcide Pharmaceuticals 1998 - 2000
Skills
In Vivo, WinNonlin, Mouse Handling, Protocol Design, ELISA, xenograft model, PCR, Western Blotting, Plasma Processing, Cell Culture, Blood Collection, SOP authoring, Dosing, orthotopic models, Report Writing
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1995
Bachelor of Arts (BA), Biomedical Sciences, General
Thomas L. Hall's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience April 2012 - Present
Job Manager GCP Training, OLAD Organizational Learning & Development
Industry Pharmaceuticals
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - Present
PharmaNet Development Group, Inc. 2010 - January 2012
PharmaNet Development Group, Inc. September 2009 - October 2010
Skills
Pharmaceuticals, GCP, ICH-GCP, Strategic Planning, Leadership Development, Pharmaceutics, GMP, Clinical Trials, CRO, Immunology, Training, Pharmaceutical Industry, Oncology, Biopharmaceuticals, Clinical Development, Management, Project Management, Clinical Research, Protocol, Process Improvement, Quality Assurance, Oracle Clinical, Sop, Validation, Medical Writing, Clinical Monitoring, Data Management, Drug Development, EDC, Dermatology, Lifesciences, 21 CFR Part 11, FDA, Pharmacovigilance, Clinical Operations, Cross-functional Team..., Therapeutic Areas, CTMS, Infectious Diseases, GLP, Medical Devices, Biotechnology, Regulatory Submissions, Regulatory Affairs, Rheumatology, SOP
Education
CMU 2002 — 2007
Doctor of Health Administration, Health Administration
CMU 2002 — 2007
Master of Science (M.S.), Health Administration
Rutgers University-New Brunswick 1973 — 1978
BA, Biology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2012 - Present
PharmaNet Development Group, Inc. 2010 - January 2012
PharmaNet Development Group, Inc. September 2009 - October 2010
Skills
Pharmaceuticals, GCP, ICH-GCP, Strategic Planning, Leadership Development, Pharmaceutics, GMP, Clinical Trials, CRO, Immunology, Training, Pharmaceutical Industry, Oncology, Biopharmaceuticals, Clinical Development, Management, Project Management, Clinical Research, Protocol, Process Improvement, Quality Assurance, Oracle Clinical, Sop, Validation, Medical Writing, Clinical Monitoring, Data Management, Drug Development, EDC, Dermatology, Lifesciences, 21 CFR Part 11, FDA, Pharmacovigilance, Clinical Operations, Cross-functional Team..., Therapeutic Areas, CTMS, Infectious Diseases, GLP, Medical Devices, Biotechnology, Regulatory Submissions, Regulatory Affairs, Rheumatology, SOP
Education
CMU 2002 — 2007
Doctor of Health Administration, Health Administration
CMU 2002 — 2007
Master of Science (M.S.), Health Administration
Rutgers University-New Brunswick 1973 — 1978
BA, Biology
Jaime Ramilo's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience October 2011 - December 2012
Job Clinical Supply Planning
Industry Pharmaceuticals
Experience
Eli Lilly and Company December 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2011 - December 2012
Theradex® January 2007 - May 2011
Phyton Biotech March 2006 - December 2006
Skills
SOP, GMP, FDA, Biotechnology, CAPA, 21 CFR Part 11, Validation, Life Sciences, Project Management, Manufacturing, CTMS, Clinical Supplies, CRO, Clinical Development, Cross-functional Team..., Oncology, Clinical Research, Computer System..., SAP, Biopharmaceuticals, Change Management, Drug Development, R&D
Education
Seton Hall University 2002 — 2006
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Eli Lilly and Company December 2012 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company October 2011 - December 2012
Theradex® January 2007 - May 2011
Phyton Biotech March 2006 - December 2006
Skills
SOP, GMP, FDA, Biotechnology, CAPA, 21 CFR Part 11, Validation, Life Sciences, Project Management, Manufacturing, CTMS, Clinical Supplies, CRO, Clinical Development, Cross-functional Team..., Oncology, Clinical Research, Computer System..., SAP, Biopharmaceuticals, Change Management, Drug Development, R&D
Education
Seton Hall University 2002 — 2006
Bachelor of Science (B.S.), Biology/Biological Sciences, General
wayne mcfarland's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience 2000 - 2006
Job Senior Director GxP Operations Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals May 2012 - Present
Diversified Project Management November 2011 - May 2012
BMS December 2006 - October 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2000 - 2006
BASF Bioresearch Corp 1995 - 2000
Skills
Biotechnology, Change Control, Engineering, FDA, GMP, GxP, Pharmaceutical Industry, Project Engineering, Sop, Validation, CAPA, 21 CFR Part 11, V, Aseptic Processing
Education
Tufts University 1997 — 1999
Masters Engineering Management
Stevens Institute of Technology 1992 — 1995
BE, Chemical Engineering
Vertex Pharmaceuticals May 2012 - Present
Diversified Project Management November 2011 - May 2012
BMS December 2006 - October 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2000 - 2006
BASF Bioresearch Corp 1995 - 2000
Skills
Biotechnology, Change Control, Engineering, FDA, GMP, GxP, Pharmaceutical Industry, Project Engineering, Sop, Validation, CAPA, 21 CFR Part 11, V, Aseptic Processing
Education
Tufts University 1997 — 1999
Masters Engineering Management
Stevens Institute of Technology 1992 — 1995
BE, Chemical Engineering
Jo Anne Sicat's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience May 2008 - July 2010
Job Director, Pharmacovigilance Operations at The Medicines Company
Industry Pharmaceuticals
Experience
The Medicines Company July 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - July 2010
Sanofi May 2006 - May 2008
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Oncology, Biotechnology, Cardiology, Drug Development, Regulatory Affairs, Regulatory Submissions, Product Launch, CRO, Lifesciences, GCP
Education
Seton Hall University 1998 — 2001
Master of Science in Nursing (MSN), Pediatric Nurse Practitioner
Cebu Velez College 1990 — 1994
Bachelor of Science (BS), Registered Nursing/Registered Nurse
The Medicines Company July 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2008 - July 2010
Sanofi May 2006 - May 2008
Skills
Pharmaceutical Industry, Clinical Development, Clinical Trials, Oncology, Biotechnology, Cardiology, Drug Development, Regulatory Affairs, Regulatory Submissions, Product Launch, CRO, Lifesciences, GCP
Education
Seton Hall University 1998 — 2001
Master of Science in Nursing (MSN), Pediatric Nurse Practitioner
Cebu Velez College 1990 — 1994
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Evgeniy Slinin's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2011 - August 2011
Job Laboratory Supervisor at Touro College
Industry Higher Education
Experience
Touro College September 2011 - Present
St. Francis College September 2010 - Present
Touro College February 2012 - June 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2011 - August 2011
Eli Lilly and Company June 2011 - August 2011
Francis College July 2008 - July 2009
St. Francis College January 2009 - May 2009
Francis College September 2007 - May 2008
Montage May 2007 - March 2008
Skills
Computers, Computer Graphics, Programming, Web Design, E-Learning, Chemistry, Tutoring, Academic Tutoring, Laboratory, Ebay Sales, Academic Advising, Physics, Protein Chemistry, Higher Education, Teaching, Biology, Organic Chemistry
Education
St. Francis College 2006 — 2009
Bachelor of Science (B.S.), Chemistry, 3.71
Touro College September 2011 - Present
St. Francis College September 2010 - Present
Touro College February 2012 - June 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2011 - August 2011
Eli Lilly and Company June 2011 - August 2011
Francis College July 2008 - July 2009
St. Francis College January 2009 - May 2009
Francis College September 2007 - May 2008
Montage May 2007 - March 2008
Skills
Computers, Computer Graphics, Programming, Web Design, E-Learning, Chemistry, Tutoring, Academic Tutoring, Laboratory, Ebay Sales, Academic Advising, Physics, Protein Chemistry, Higher Education, Teaching, Biology, Organic Chemistry
Education
St. Francis College 2006 — 2009
Bachelor of Science (B.S.), Chemistry, 3.71
Jennifer DeMaio's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2010 - Present
Job QA Compliance Senior Engineer at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2007 - June 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - November 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2005 - July 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2003 - January 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2001 - January 2003
Skills
GMP, Quality Assurance, Change Management, Change Control, Compliance, Deviation Management, NCEs, Cell Culture, Fermentation, Media Preparation, Batch Records, SOP development
Education
Rutgers University
Bachelor of Arts (B.A.), Biology, General
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2007 - June 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2006 - November 2007
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2005 - July 2006
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2003 - January 2005
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2001 - January 2003
Skills
GMP, Quality Assurance, Change Management, Change Control, Compliance, Deviation Management, NCEs, Cell Culture, Fermentation, Media Preparation, Batch Records, SOP development
Education
Rutgers University
Bachelor of Arts (B.A.), Biology, General
Allison Inguanti's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience January 2006 - February 2007
Job Sales Engineer at Control Associates
Industry Industrial Automation
Experience
Control Associates February 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2006 - February 2007
Skills
Process Automation, Process Control, Automation
Education
Stevens Institute of Technology 2001 — 2005
Bachelor of Engineering (B.E.), Biomedical Engineering
Control Associates February 2007 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2006 - February 2007
Skills
Process Automation, Process Control, Automation
Education
Stevens Institute of Technology 2001 — 2005
Bachelor of Engineering (B.E.), Biomedical Engineering
Jason Sootkoos's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2008 - April 2013
Job Project Manager at Eli Lilly and Company
Industry Biotechnology
Experience
Eli Lilly and Company April 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2008 - April 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2002 - August 2008
Skills
Protein Purification, Project Management, Monoclonal Antibodies, Biotechnology, Biopharmaceuticals, Jeep, Numismatics, Observational Astronomy, Fishing, Hunting, Shooting Sports, Camping, Hiking, Winemaking, Gunsmithing, Automotive Repair, FDA, Validation, GMP, SOP, 21 CFR Part 11, CAPA, Change Control, Technology Transfer
Education
Stevens Institute of Technology 2006 — 2009
Master of Science (MS), Pharmaceutical Manufacturing
Syracuse University 1997 — 2001
Bachelor of Science (BS), Psychology
Syracuse University 1997 — 2001
Bachelor of Arts (BA), Biology, General
Eli Lilly and Company April 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2008 - April 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2002 - August 2008
Skills
Protein Purification, Project Management, Monoclonal Antibodies, Biotechnology, Biopharmaceuticals, Jeep, Numismatics, Observational Astronomy, Fishing, Hunting, Shooting Sports, Camping, Hiking, Winemaking, Gunsmithing, Automotive Repair, FDA, Validation, GMP, SOP, 21 CFR Part 11, CAPA, Change Control, Technology Transfer
Education
Stevens Institute of Technology 2006 — 2009
Master of Science (MS), Pharmaceutical Manufacturing
Syracuse University 1997 — 2001
Bachelor of Science (BS), Psychology
Syracuse University 1997 — 2001
Bachelor of Arts (BA), Biology, General
PAUL ATALLA's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience November 2006 - April 2010
Job QC Supervisor Environmental Monitoring at Regeneron Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Regeneron Pharmaceuticals, Inc. March 2014 - Present
Alexion Pharmaceuticals, Inc. May 2010 - February 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - April 2010
Wyeth Pharmaceuticals (now Pfizer) March 2000 - November 2006
Skills
Mobile Data..., Trackwise, Nexdocs, Darwin, LIMS, Microsoft Office, Water Sampling, Water Testing, Product Testing, Environmental Monitoring, Organism ID, Sterility Testing, Consumer Health Testing, Documents Author, Trend Reports Author, Data Management and...
Education
William Paterson University of New Jersey
Master of Science (MS), Biotechnology, Cumulative GPA 3.859
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (BA), Biology, General, Cumulative GPA 3.3
Regeneron Pharmaceuticals, Inc. March 2014 - Present
Alexion Pharmaceuticals, Inc. May 2010 - February 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2006 - April 2010
Wyeth Pharmaceuticals (now Pfizer) March 2000 - November 2006
Skills
Mobile Data..., Trackwise, Nexdocs, Darwin, LIMS, Microsoft Office, Water Sampling, Water Testing, Product Testing, Environmental Monitoring, Organism ID, Sterility Testing, Consumer Health Testing, Documents Author, Trend Reports Author, Data Management and...
Education
William Paterson University of New Jersey
Master of Science (MS), Biotechnology, Cumulative GPA 3.859
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (BA), Biology, General, Cumulative GPA 3.3
Victor Goetz's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience June 2002 - Present
Job AVP, Process Sciences at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2002 - Present
Rohm & Haas December 1999 - June 2002
Merck & Co., Inc.. June 1992 - June 2002
Skills
Biochemical Engineering, Biotechnology, Technology Transfer, Protein Purification, Cell Culture, Biopharmaceuticals, Purification, Protein Chemistry, Life Sciences, Pharmaceutical Industry, R&D, Process Simulation, GMP, Biochemistry, Validation
Education
Stanford University
Bachelor of Science (BS), Chemical Engineering
University of Pennsylvania
Doctor of Philosophy (PhD), Chemical and Biochemical Engineering
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2002 - Present
Rohm & Haas December 1999 - June 2002
Merck & Co., Inc.. June 1992 - June 2002
Skills
Biochemical Engineering, Biotechnology, Technology Transfer, Protein Purification, Cell Culture, Biopharmaceuticals, Purification, Protein Chemistry, Life Sciences, Pharmaceutical Industry, R&D, Process Simulation, GMP, Biochemistry, Validation
Education
Stanford University
Bachelor of Science (BS), Chemical Engineering
University of Pennsylvania
Doctor of Philosophy (PhD), Chemical and Biochemical Engineering
colin mangan's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience
Job Supervisor at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
Skills
CAPA, SOP, GMP, FDA, Biotechnology, Biopharmaceuticals, 21 CFR Part 11, Pharmaceutical Industry, Aseptic Processing, Validation
Education
Rutgers, The State University of New Jersey-Newark 1999 — 2002
Bachelor of Science (BS), Biology/Biological Sciences, General
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
Skills
CAPA, SOP, GMP, FDA, Biotechnology, Biopharmaceuticals, 21 CFR Part 11, Pharmaceutical Industry, Aseptic Processing, Validation
Education
Rutgers, The State University of New Jersey-Newark 1999 — 2002
Bachelor of Science (BS), Biology/Biological Sciences, General
Tony Pucci's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience March 2008 - April 2009
Job Financial Specialist, Clinical Development at Merck
Industry Pharmaceuticals
Experience
Merck May 2015 - Present
inVentiv Health Clinical December 2013 - April 2015
Covance May 2012 - November 2013
Watson Pharma Inc. October 2011 - April 2012
Covance May 2009 - October 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2008 - April 2009
ORGANON USA March 2007 - March 2008
Skills
Contract Management, Cross-functional Team..., Budgets, Pharmaceutical Industry, Analysis, GCP, Negotiation, Business Development, CRO
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2002
Bachelor of Arts (B.A.), Journalism and Media Studies
Rutgers University-New Brunswick
Merck May 2015 - Present
inVentiv Health Clinical December 2013 - April 2015
Covance May 2012 - November 2013
Watson Pharma Inc. October 2011 - April 2012
Covance May 2009 - October 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2008 - April 2009
ORGANON USA March 2007 - March 2008
Skills
Contract Management, Cross-functional Team..., Budgets, Pharmaceutical Industry, Analysis, GCP, Negotiation, Business Development, CRO
Education
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2002
Bachelor of Arts (B.A.), Journalism and Media Studies
Rutgers University-New Brunswick
Patrick Perone's ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company Experience August 2007 - February 2009
Job Contract Manager at PRA Health Sciences
Industry Pharmaceuticals
Experience
PRA Health Sciences August 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - February 2009
Private Practice of Law October 1993 - July 2007
NJ Deptartment of Health and Senior Services January 2001 - March 2002
Superior Court of New Jersey September 1992 - September 1993
Skills
Microsoft Office, Microsoft Excel, Microsoft Word
Education
Widener University School of Law 1989 — 1992
Juris Doctor (J.D.), Law
Rutgers University-New Brunswick 1984 — 1989
Bachelor’s Degree, Economics
PRA Health Sciences August 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2007 - February 2009
Private Practice of Law October 1993 - July 2007
NJ Deptartment of Health and Senior Services January 2001 - March 2002
Superior Court of New Jersey September 1992 - September 1993
Skills
Microsoft Office, Microsoft Excel, Microsoft Word
Education
Widener University School of Law 1989 — 1992
Juris Doctor (J.D.), Law
Rutgers University-New Brunswick 1984 — 1989
Bachelor’s Degree, Economics